Information service
11.040 Medical equipment
New standards
EVS-EN ISO 18777-1:2026
Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO 18777-1:2026)
Scope: This document specifies requirements for transportable liquid oxygen systems that are common to both base units and portable units and requirements that are particular to base units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1 Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2 ISO 18777 - 2 specifies those requirements particular to portable units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1 Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2 ISO 18777 - 2 specifies those requirements particular to portable units.
Base documents: ISO 18777-1:2026; EN ISO 18777-1:2026
Replaces: EVS-EN ISO 18777:2009
EVS-EN ISO 11979-4:2026
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2026)
Scope: This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
Base documents: ISO 11979-4:2026; EN ISO 11979-4:2026
ISO/TR 4234:2026
Non-active surgical implants — Implant coating — Best practices for coating system assessment
Scope: This document specifies a systematic approach for the development of an assessment plan for coating systems for potential use for implants. This document provides brief introductory guidance on the coating system and intended functions. This document describes the assessment process from the context of product design, manufacturing (including sterilization), product aging and clinical intended use. This assessment process is intended to help evaluate coating properties that are pertinent to the performance of the coated devices and uses relevant examples to illustrate the process.
NOTE ISO 17327-1 defines a set of coating properties that can be pertinent for any specific coating.
This document is intended to be a useful tool in the development of an assessment plan of coating systems and is meant to support communication, e.g. among coatings manufacturer, original equipment manufacturer and regulatory bodies (through direct interaction or master files).
This document does not address the clinical safety and performance of the surgical implant for which the coating system is a part.
This document also does not cover specific tests for coating systems, as it is intended to be a structure for determining important properties and tests that can be appropriate for any given coating system.
NOTE ISO/TR 17327-2 provides several tables listing standards related to coatings including some known test methods.
NOTE ISO 17327-1 defines a set of coating properties that can be pertinent for any specific coating.
This document is intended to be a useful tool in the development of an assessment plan of coating systems and is meant to support communication, e.g. among coatings manufacturer, original equipment manufacturer and regulatory bodies (through direct interaction or master files).
This document does not address the clinical safety and performance of the surgical implant for which the coating system is a part.
This document also does not cover specific tests for coating systems, as it is intended to be a structure for determining important properties and tests that can be appropriate for any given coating system.
NOTE ISO/TR 17327-2 provides several tables listing standards related to coatings including some known test methods.
Base documents:
ISO 11979-1:2026
Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
Scope: This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms.
NOTE The terms are listed in the alphabetical order of the English terms.
Base documents:
Replaces: ISO 11979-1:2018
Replaced standards
EVS-EN ISO 11979-4:2009
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
Scope: This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
Base documents: ISO 11979-4:2008; EN ISO 11979-4:2008
Replaced: EVS-EN ISO 11979-4:2026
EVS-EN ISO 11979-4:2009/A1:2012
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
Scope: This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
Base documents: ISO 11979-4:2008/Amd 1:2012; EN ISO 11979-4:2008/A1:2012
Replaced: EVS-EN ISO 11979-4:2026
ISO 11979-1:2018
Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary
Scope: This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them.
NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.
NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.
Base documents:
Replaced: ISO 11979-1:2026
Drafts
prEN ISO 22523
External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2026)
Scope: This document specifies requirements and test methods for external limb prostheses and external orthoses,
including the following classifications from ISO 9999:
06 03 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document covers strength, materials, restrictions on use, risk and the provision of information
associated with the normal conditions of use of both components and assemblies of components. This
document is also applicable as guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.
including the following classifications from ISO 9999:
06 03 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document covers strength, materials, restrictions on use, risk and the provision of information
associated with the normal conditions of use of both components and assemblies of components. This
document is also applicable as guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.
Base documents: prEN ISO 22523; ISO/DIS 22523:2026
prEN ISO 8836
Anaesthetic and respiratory equipment - Suction catheters for use in the respiratory tract (ISO/DIS 8836:2026)
Scope: This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
Base documents: ISO/DIS 8836; prEN ISO 8836