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11 Health care technology
New standards
EVS-EN ISO 13408-1:2024
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
Scope:
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Base documents:
ISO 13408-1:2023; EN ISO 13408-1:2024
Replaces:
EVS-EN ISO 13408-1:2015
EVS-EN ISO 8637-2:2024
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Scope:
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Base documents:
ISO 8637-2:2024; EN ISO 8637-2:2024
Replaces:
EVS-EN ISO 8637-2:2018
EVS-EN ISO 23500-4:2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
Scope:
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
— concentrates in both liquid and powder forms;
— additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
— equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
— concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
— pre-packaged and sterile dialysis fluid;
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
— equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document is applicable to:
— concentrates in both liquid and powder forms;
— additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
— equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
— concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
— pre-packaged and sterile dialysis fluid;
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
— equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
Base documents:
ISO 23500-4:2024; EN ISO 23500-4:2024
Replaces:
EVS-EN ISO 23500-4:2019
EVS-EN ISO 23500-3:2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
Scope:
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
— water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
— water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
This document is applicable to
— water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
— water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
Base documents:
ISO 23500-3:2024; EN ISO 23500-3:2024
Replaces:
EVS-EN ISO 23500-3:2019
EVS-EN ISO 23500-5:2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
Scope:
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
Base documents:
ISO 23500-5:2024; EN ISO 23500-5:2024
Replaces:
EVS-EN ISO 23500-5:2019
EVS-EN ISO 16571:2024
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Scope:
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
Base documents:
ISO 16571:2024; EN ISO 16571:2024
EVS-EN ISO 5832-7:2024
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)
Scope:
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
Base documents:
ISO 5832-7:2024; EN ISO 5832-7:2024
Replaces:
EVS-EN ISO 5832-7:2019
EVS-EN ISO 5832-1:2024
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
Scope:
ISO 5832-1 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
While no known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body, long-term clinical experience with the material referred to in ISO 5832-1 has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications.
However, this standard covers the raw material and not finished medical devices, where the design and fabrication of the device can impact biological response.
ISO 5832-1:2024 text has been approved in Europe as EN ISO 5832-1:2024 without any changes.
Base documents:
ISO 5832-1:2024; EN ISO 5832-1:2024
Replaces:
EVS-EN ISO 5832-1:2019
ISO 23500-5:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Scope:
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
Base documents:
Replaces:
ISO 23500-5:2019
ISO 23500-4:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
Scope:
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
— concentrates in both liquid and powder forms;
— additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
— equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
— concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
— pre-packaged and sterile dialysis fluid;
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
— equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document is applicable to:
— concentrates in both liquid and powder forms;
— additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
— equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
— concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
— pre-packaged and sterile dialysis fluid;
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
— equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
Base documents:
Replaces:
ISO 23500-4:2019
ISO 23500-3:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
Scope:
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
— water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
— water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
This document is applicable to
— water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
— water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
Base documents:
Replaces:
ISO 23500-3:2019
ISO 5832-7:2024
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
Scope:
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
Base documents:
Replaces:
ISO 5832-7:2016
ISO 8637-2:2024
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Scope:
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Base documents:
Replaces:
ISO 8637-2:2018
ISO 5363:2024
Robotics — Test methods for exoskeleton-type walking RACA robot
Scope:
This document specifies test methods for the exoskeleton-type walking RACA robot used as medical electrical equipment which is intended to move from one location to another, by making reciprocating motion having intermittent contact with the travel surface.
This document does not apply to passive or non-powered exoskeletons.
NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.
This document does not apply to passive or non-powered exoskeletons.
NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.
Base documents:
EVS-EN 60601-1:2006/A13:2024
Medical electrical equipment - Part 1: General requirements for safety
Scope:
Amendment to EN 60601-1:2006
Base documents:
EN 60601-1:2006/A13:2024
ISO 7151:2024
Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
Scope:
This document specifies general requirements and corresponding test methods for a general range of non-cutting instruments in surgery.
Base documents:
Replaces:
ISO 7151:1988
ISO 16840-10:2021/Amd 1:2024
Wheelchair seating — Part 10: Resistance to ignition of postural support devices — Requirements and test method — Amendment 1: Amended with additional Annexes and test method
Scope:
Amendment to ISO 16840-10:2021
Base documents:
CWA 18105:2024
Assessing machine learning-based pandemic crisis prediction and management tools in STADEM trials
Scope:
Method to assess pandemic crises prediction for the CEN member states
Base documents:
CWA 18105:2024
ISO 6904:2024
Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs
Scope:
This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.
Base documents:
ISO 23402-3:2024
Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 3: Portable suction equipment
Scope:
This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.
This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment.
The requirements in this document focus on portability.
This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments.
This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.
This document specifies requirements for portable suction equipment used to provide reduced pressure and flow at the cannula connector.
This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.
This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment.
The requirements in this document focus on portability.
This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments.
This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.
This document specifies requirements for portable suction equipment used to provide reduced pressure and flow at the cannula connector.
This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.
Base documents:
ISO/TS 16840-15:2024
Wheelchair seating — Part 15: Selection, placement and fixation of flexible postural support devices in seating
Scope:
This document specifies requirements for the selection, placement and fixation of flexible postural support devices within seating devices and systems and to chairs, including wheelchairs and bathroom equipment. Seating devices can be involved in one or more situations, including hoists, static seating, wheelchair seating, shower chairs, etc. The devices enable the seated person (the occupant) to be positioned to maximize their functional activities in a safe environment. These requirements are formulated to achieve a balance of posture maintenance and safety.
This document covers flexible positioning supports (padded or otherwise) used for postural positioning and/or safety. It does not cover belts and harnesses used in transportation for restraint, postural support devices made from rigid materials such as metal, wood, or hard plastics, or postural support devices designed solely for use in sports-related seating.
This document covers flexible positioning supports (padded or otherwise) used for postural positioning and/or safety. It does not cover belts and harnesses used in transportation for restraint, postural support devices made from rigid materials such as metal, wood, or hard plastics, or postural support devices designed solely for use in sports-related seating.
Base documents:
ISO 16840-2:2018/Amd 1:2024
Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity — Amendment 1: Updates and addition of new Annex covering alternatively sized cushions
Scope:
Amendment to ISO 16840-2:2018
Base documents:
IEC TS 60601-4-6:2024
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
Scope:
IEC TS 60601-4-6:2024 provides practical methods to help achieve basic safety and essential performance with regard to the possible effects of em disturbances throughout the expected service life of me equipment or an me system.
These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by em disturbances in me equipment or me systems.
The purpose of this document is to provide recommendations for the techniques and measures used in the design, verification, and validation of systems, hardware, software, and firmware used in me equipment or me systems to help achieve basic safety and essential performance with regard to the em disturbances that could occur throughout the expected service life.
These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by em disturbances in me equipment or me systems.
The purpose of this document is to provide recommendations for the techniques and measures used in the design, verification, and validation of systems, hardware, software, and firmware used in me equipment or me systems to help achieve basic safety and essential performance with regard to the em disturbances that could occur throughout the expected service life.
Base documents:
Replaced standards
EVS-EN ISO 13408-1:2015
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Scope:
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
Base documents:
ISO 13408-1:2008; ISO 13408-1:2008/Amd 1:2013; EN ISO 13408-1:2015
Replaced:
EVS-EN ISO 13408-1:2024
EVS-EN ISO 8637-2:2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Scope:
This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and
transducer protectors (integral and non-integral) intended for use in such circuits.
This International Standard does not apply to:
-haemodialysers, haemodiafilters or haemofilters;
-plasmafilters;
-haemoperfusion devices;
-vascular access devices;
-blood pumps;
-pressure monitors for the extracorporeal blood circuit;
-air detection devices;
-systems to prepare, maintain or monitor dialysis fluid;
-systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in
ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3
NOTE Extracoproreal blood tubing sets may also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
transducer protectors (integral and non-integral) intended for use in such circuits.
This International Standard does not apply to:
-haemodialysers, haemodiafilters or haemofilters;
-plasmafilters;
-haemoperfusion devices;
-vascular access devices;
-blood pumps;
-pressure monitors for the extracorporeal blood circuit;
-air detection devices;
-systems to prepare, maintain or monitor dialysis fluid;
-systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in
ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3
NOTE Extracoproreal blood tubing sets may also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
Base documents:
EN ISO 8637-2:2018; ISO 8637-2:2018
Replaced:
EVS-EN ISO 8637-2:2024
ISO 5832-7:2016
Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
Scope:
ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
Base documents:
Replaced:
ISO 5832-7:2024
EVS-EN ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
Scope:
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
Base documents:
ISO 23500-3:2019; EN ISO 23500-3:2019
Replaced:
EVS-EN ISO 23500-3:2024
EVS-EN ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
Scope:
This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
Base documents:
ISO 23500-4:2019; EN ISO 23500-4:2019
Replaced:
EVS-EN ISO 23500-4:2024
ISO 7151:1988
Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
Scope:
Specification of basic requirements for as well physical characteristics as workmanship, of the steel grades used and heat treatment of component parts, excluding rivets, screws and parts manufactured of material grade M.
Base documents:
Replaced:
ISO 7151:2024
ISO 8637-2:2018
Extracorporeal systems for blood purification -- Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Scope:
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.
NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
This document does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.
NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
Base documents:
Replaced:
ISO 8637-2:2024
EVS-EN ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
Scope:
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
Base documents:
ISO 23500-5:2019; EN ISO 23500-5:2019
Replaced:
EVS-EN ISO 23500-5:2024
EVS-EN ISO 5832-7:2019
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
Scope:
ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
Base documents:
ISO 5832-7:2016; EN ISO 5832-7:2019
Replaced:
EVS-EN ISO 5832-7:2024
ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies -- Part 4: Concentrates for haemodialysis and related therapies
Scope:
This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
Base documents:
Replaced:
ISO 23500-4:2024
EVS-EN ISO 5832-1:2019
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
Scope:
ISO 5832-1:2016 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
Base documents:
ISO 5832-1:2016; EN ISO 5832-1:2019
Replaced:
EVS-EN ISO 5832-1:2024
ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies -- Part 3: Water for haemodialysis and related therapies
Scope:
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
Base documents:
Replaced:
ISO 23500-3:2024
ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies -- Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Scope:
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
Base documents:
Replaced:
ISO 23500-5:2024
Drafts
prEN 868-4
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Scope:
This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Base documents:
prEN 868-4
prEN 868-6
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Scope:
This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Base documents:
prEN 868-6
prEN 868-7
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Scope:
This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Base documents:
prEN 868-7
prEN 868-2
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Scope:
This document specifies test methods and values for sterilization wrap made of
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Base documents:
prEN 868-2
prEN 868-3
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Scope:
This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Base documents:
prEN 868-3
prEN 17984-2
Assistance dogs - Part 2: Dog lifetime welfare
Scope:
The purpose of this document is to protect the welfare of assistance dogs. For this, it sets out requirements based on the Five Domains Paradigm to ensure the dog’s welfare.
The requirements apply:
- throughout the whole life of the dog;
- for all types of assistance dogs;
- for all people/caregivers/handlers who are entrusted with a dog at any point during its lifetime.
The requirements apply:
- throughout the whole life of the dog;
- for all types of assistance dogs;
- for all people/caregivers/handlers who are entrusted with a dog at any point during its lifetime.
Base documents:
prEN 17984-2
prEN ISO 8871-5
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024)
Scope:
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
Base documents:
ISO/DIS 8871-5; prEN ISO 8871-5