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New Standards

ISO 14242-1:2012
Price 54.29 EUR
Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test


ISO/IEC Guide 63:2012
Price 88.85 EUR
Guide to the development and inclusion of safety aspects in International Standards for medical devices


ISO 5360:2012
Price 88.85 EUR
Anaesthetic vaporizers -- Agent-specific filling systems


ISO 11040-3:2012
Price 41.13 EUR
Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges


ISO 11040-5:2012
Price 41.13 EUR
Prefilled syringes -- Part 5: Plunger stoppers for injectables


ISO 11979-7:2006/Amd 1:2012
Price 13.16 EUR
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations AMENDMENT 1


EVS-EN ISO 5360:2012
Price 11.38 EUR
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)
This International Standard specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. This International Standard does not specify construction materials. NOTE 1 For recommendations on materials, see Annex A. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard. NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.

Replaced Standards

EVS-EN ISO 5360:2009
Anaesthetic vaporizers - Agent-specific filling systems
This International Standard specifies the dimensions of agent-specific filling systems for agent-specific anaesthetic vaporizers. This International Standard does not specify construction materials. Materials used for the parts of filling systems which come into contact with liquid anaesthetic agent should be selected with regard to: a) toxicity; b) compatibility with anaesthetic agents; c) minimization of health risks due to substances leached from the materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard.
Language: English

ISO 5360:2006
Anaesthetic vaporizers -- Agent-specific filling systems

Language: English

ISO 14242-1:2002
Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

Language: English

ISO 11040-5:2001
Prefilled syringes -- Part 5: Plungers for injectables

Language: English

ISO 11040-3:1993
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges

Language: English

ISO/IEC Guide 63:1999
Guide to the development and inclusion of safety aspects in International Standards for medical devices

Language: English

Drafts

FprEN 60601-2-16
Deadline 3/31/2012
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. This International Standard does not take into consideration the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY SYSTEMS. It does however take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This International Standard specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These devices are intended for use either by medical staff or for use by the PATIENT or other trained personnel under the supervision of medical expertise. This International Standard includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering from kidney failure. The particular requirements in this International standard do not apply to: - EXTRACORPOREAL CIRCUITS; - DIALYSERS; - DIALYSIS FLUID CONCENTRATES; - water treatment equipment; - equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
Language: English

prEN 16372
Deadline 3/31/2012
Aesthetic surgery services
This European Standard addresses the requirements for clinical aesthetic practice: This covers both surgical and non-surgical medical services to patients to change physical appearance. This European Standard provides recommendations for procedures for clinical treatment, including the ethical framework and general principles according to which clinical services are provided by all aesthetic practitioners. These recommendations apply before, during and after the procedure. Dentistry1) procedures are excluded from the scope of this European Standard. Aesthetic non-medical procedures (e.g. tattoos, piercing) provided by non physicians (e.g. beauticians, masseurs, hairdressers) in non-medical facilities (such as spas, salons) are excluded from the scope of this European Standard.
Language: English

FprEN 60601-2-62
Deadline 3/31/2012
Medical electrical equipment - Part 2-62: Particular requirements for basic safety and essential performance of high intensity therapeutic ultrasound (HITU) systems
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.219, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the General Standard. NOTE 2 See Annex AA for a few examples of equipment for which this standard should be used. This Particular Standard does not apply to: - ULTRASOUND EQUIPMENT intended to be used for physiotherapy (use: IEC 60601-2-5 [1] and - IEC 61689) - ULTRASOUND EQUIPMENT intended to be used for lithotripsy (use: IEC 60601-2-36 [2]) - ULTRASOUND EQUIPMENT intended to be used for general pain relief (see also Annex AA)
Language: English

FprEN 60601-1-12
Deadline 3/31/2012
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1. NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use. NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1. NOTE 3 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical sources and outdoor environmental conditions.
Language: English

EN 80601-2-30:2010/FprA1
Deadline 3/31/2012
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
This International Standard applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable CUFF, are used for intermittent indirect measurement of the blood pressure without arterial puncture.
Language: English

EN ISO 7405:2009/prA1
Deadline 3/31/2012
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1 (ISO 7405:2008/DAM 1:2012)
This International Standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
Language: English

EN ISO 8536-4:2010/prA1
Deadline 3/31/2012
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/DAM 1:2011)
This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Language: English

prEN ISO 80601-2-67
Deadline 3/31/2012
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2012)
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen CONSERVING EQUIPMENT, hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES intended to conserve oxygen by delivering supplemental oxygen intermittently and synchronized to the PATIENT'S inspiratory flow, when used in the HOME HEALTHCARE ENVIRONMENT. Oxygen CONSERVING EQUIPMENT is typically used by a LAY OPERATOR.
Language: English