International Standards
This article was originally published in SRA
Executive Summary
Recently published or recognised international and regional standards relating to the medical device sector.
Recently published or recognised international and regional standards relating to the medical device sector.
International
International Electrotechnical Commission (IEC)
Number | Title |
IEC 60522 Ed. 2.0 b:1999 | Determination of the permanent filtration of X-ray tube assemblies |
IEC 60601-2-29 Ed. 3.0 b:2008 | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
IEC 60977 Ed. 2.0 | Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics |
IEC 61675-1 Ed. 1.1 | Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs |
IEC 62220-1-3 Ed. 1.0 b:2008 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
Project IEC 80601-2-59 Ed. 1.0 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
International Organization for Standardization (ISO)
Number | Title |
ISO 3823-2/Amd1:2008 | Dental rotary instruments - Part 2: Steel and carbide finishing burs - Amendment 1 |
ISO 5359:2008 | Low-pressure hose assemblies for use with medical gases |
ISO 5364:2008 | Anaesthetic and respiratory equipment - Oropharyngeal airways |
ISO 9170-1:2008 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases |
ISO 9170-2:2008 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems |
ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators |
ISO 11143:2008 | Dentistry - Amalgam separators |
ISO 13356:2008 | Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
ISO 13408-1:2008 | Aseptic processing of health care products - Part 1: General requirements |
ISO 13779-3:2008 | Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity and phase purity |
ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
ISO 16402:2008 | Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics |
ISO 24157:2008 | Ophthalmic optics and instruments - Reporting aberrations of the human eye |
ISO 27799:2008 | Health informatics - Information security management in health using ISO/IEC 27002 |
Number | Title | Comments due |
IEC/DIS 80601-2-35 | Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use | Not available |
ISO/DIS 1135-4 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use | Not available |
ISO/DIS 9917-2 | Dentistry - Water-based cements - Part 2: Resin-modified cements | 5 October 2008 |
ISO/DIS 11712 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors | Not available |
ISO/DIS 15225 | Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange | Not available |
ISO/DIS 20795-2 | Dentistry - Base polymers - Part 2: Orthodontic base polymers | Not available |
ISO/DIS 23409 | Male condoms - Requirements and test methods for condoms made from synthetic materials | 16 August 2008 |
ISO/DIS 25424 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices | 13 September 2008 |
ISO/DIS 27186 | Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements | Not available |
ISO/DIS 81060-2 | Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type | 14 September 2008 |
US
Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI)
Title | Status | |
ANSI/AAMI/ISO 15223-1-2007/A1-2008 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Supplement to ANSI/AAMI/ISO 15223-1:2007. Effective 6 June 2008 |
ANSI/ADA Specification No 113-2208 | Periodontal Curettes, Dental Scalers and Excavators | National adoption with modifications of ISO 13397-2. Effective 3 July 2008 |
BSR/AAMI/ISO 10993-17-2002 (R200x) | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | Reaffirmation of ANSI/AAMI/ISO 10993-17-2002. Comments were due 14 July 2008 |
BSR/AAMI/ISO 15223-1-200x | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements | Identical national adoption and revision of ANSI/AAMI/ISO 15223-1-2007. Comments due 19 August 2008 |
BSR/AAMI/ISO 27186-200x | Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements | Identical national adoption of ISO 27186. Comments due 25 August 2008 |
BSR/AAMI/ISO/IEC 81060-2-200x | Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type | Identical national adoption and revision of ANSI/AAMI SP10-2002, ANSI/AAMI SP10-2002/A1 and ANSI/AAMI SP10-2002/A2-2006. Comments due 25 August 2008 |
BSR/AAMI EC53-1995 (R200x) | ECG cables and leadwires | Reaffirmation of ANSI/AAMI EC53-1995 (R2001). Comments due 25 August 2008 |
BSR/AAMI EC53A-1995 (R200x) | ECG cables and leadwires | Reaffirmation of ANSI/AAMI EC53-1995 (R2001). Comments due 25 August 2008 |
BSR/AAMI EC57-1998 (R200x) | Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms | Reaffirmation of ANSI/AAMI EC57-1998 (R2003). Comments due 25 August 2008 |
BSR/AAMI RD52-2004/ A3-200x | Dialysate for hemodialysis - Amendment 3 - Annex E: Special considerations for acute dialysis | Supplement to ANSI/AAMI RD52-2004. Comments due 11 August 2008 |
BSR/AAMI ST15883-1-200x | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests | National adoption with modifications of ISO 15883-1:2006. Comments were due 14 July 2008 |
BSR/ADA Specification No 71-200x | Root Canal Filling Condensers (Pluggers and Spreaders) | National adoption with modifications and revision of ANSI/ADA 71-2001. Comments due 4 August 2008 |
BSR/HL7 V2.7-200x | Health Level Seven Standard Version 2.7 - An Application Protocol for Electronic Data Exchange in Healthcare Environments | Revision of ANSI/HL7 V2.6-2007. Comments due 4 August 2008 |
BSR/HL7 V3 CRFQSRM, R1-200x | HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM), Release 1 | Draft trial use standard. Trial use period: 21 March 2008 through 27 March 2010 |