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.
International
International Electrotechnical Commission (IEC)
Number | Title |
IEC 60601-2-2 Ed. 4.0-Bilingual | Medical electrical equipment - Part 2.2: Particular requirements for the safety of high frequency surgical equipment |
Number | Title | Comments due |
IEC 61223-2-6 Ed.2 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment | 29 September 2006 |
International Organization for Standardization (ISO)
Number | Title | |
ISO 8980-4:2006 | Ophthalmic optics - Uncut finished spectacle lenses - Part 4: Specifications and test methods for anti-reflective coatings | |
ISO 10083:2006 | Oxygen concentrator supply systems for use with medical gas pipeline systems | |
ISO 10993-11:2006 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | |
ISO 11979-9:2006 | Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses | |
ISO 11979-10:2006 | Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses | |
ISO 17655-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | |
ISO 18369-1:2006 | Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications | |
ISO 18369-2:2006 | Ophthalmic optics - Contact lenses - Part 2: Tolerances | |
ISO 18369-3:2006 | Ophthalmic optics - Contact lenses - Part 3: Measurement methods | |
ISO 18369-4:2006 | Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials | |
ISO/TS 10993-20:2006 | Medical electrical equipment - Part 2.2: Particular requirements for the safety of high frequency surgical equipment | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
ISO/TS 20993:2006 | Biological evaluation of medical devices - Guidance on a risk-management process |
Number | Title | Comments due |
ISO/DIS 7206-1 | Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions | 8 December 2006 |
ISO/DIS 8362-2 | Injection containers and accessories - Part 2: Closures for injection vials | 7 December 2006 |
ISO/DIS 9170-1.2 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum | Not available |
ISO/DIS 9170-2.2 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems | Not available |
ISO/DIS 14630 | Non-active surgical implants - General requirements | Not available |
ISO/DIS 15193 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures | 11 November 2006 |
European Standards
CEN/CENELEC
Number | Title |
CEN/TR 15299:2006 | Health informatics - Safety procedures for identification of patients and related objects |
EN ISO 8835-4:2004/AC:2006 | Inhalation anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
EN ISO 9333:2006 | Dentistry - Brazing materials (ISO 9333:2006) |
EN ISO 10271:2001/AC:2006 | Dental metallic materials - Corrosion test methods (ISO 10271:2001/Cor.1:2005) |
EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
EN ISO 21671:2006 | Dentistry - Rotary polishers (ISO 21671:2006) |
Number | Title | Status |
CEN/TC 205 N 1095 | Performance requirements and test methods for head-wear intended to be used as medical devices for patients and clinical staff | Under development |
EN 285:2006/prA1 | Sterilization - Steam sterilizers - Large sterilizers | Under approval |
EN 556-1:2006/prAC | Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices | Under development |
EN ISO 7439:2002/prA1 | Copper-bearing intrauterine contraceptive devices - Requirements, tests - Amendment 1 (ISO 7439:2002/DAMD 1:2003) | Under approval |
EN ISO 8980-1:2004/prAC | Ophthalmic optics - Uncut finished spectacle lenses - Part 1: Specifications for single-vision and multifocal lenses (ISO 8980-1:2004) | Under development |
EN ISO 8980-2:2004/prAC | Ophthalmic optics - Uncut finished spectacle lenses - Part 2: Specifications for progressive power lenses (ISO 8980-2:2004) | Under development |
prEN 15178 | Elements for the identification of products in emergency inquiries | Under approval |
prEN ISO 1942 | Dentistry - Vocabulary (ISO/DIS 1942:2005) | Under approval |
prEN ISO 6360-5 | Dental rotary instruments - Number coding system - Part 5: Specific characteristics of endodontic instruments | Under development |
prEN ISO 7405 rev | Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials | Under development |
prEN ISO 10271:2001 rev | Dental metallic materials - Corrosive test methods | Under development |
prEN ISO 10993-5:1999 rev | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under development |
prEN ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2006) | Under approval |
prEN ISO 11073-00000 | Health informatics - Point-of-care medical device communication - Part 00000: Framework and overview | Under development |
prEN ISO 11073-20201 | Health informatics - Point-of-care medical device communication - Part 20201: Application profile - Polling mode | Under development |
prEN ISO 11073-20202 | Health informatics - Point-of-care medical device communication - Part 20202: Application profile - Baseline | Under development |
prEN ISO 11609 rev | Dentistry - Toothpastes - Requirements, test methods and marking | Under development |
prEN ISO 14630 | Non-active surgical implants - General requirements (ISO/DIS 14630:2006) | Under approval |
prEN ISO 14937 rev | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | Under development |
prEN ISO 15798 rev | Ophthalmic implants - Ophthalmic viscosurgical devices | Under development |
prEN ISO 15883-4 | Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2005) | Under approval |
prEN ISO 15912 | Dentistry - Casting investments and refractory die materials (ISO/FDIS 15912:2006) | Under approval |
prEN ISO 16409 | Dentistry - Oral hygiene products - Manual interdental brushes (ISO/FDIS 16409:2006) | Under approval |
prEN ISO 18113-1 | In vitro diagnostic medical devices - Information supplied by the manufacturer - Part 1: General requirements (ISO/CD 18113-1:2006) | Under development |
prEN ISO 18113-2 | In vitro diagnostic medical devices - Information supplied by the manufacturer - Part 2: Reagents for professional use (ISO/CD 18113-2:2006) | Under development |
prEN ISO 18113-3 | In vitro diagnostic medical devices - Information supplied by the manufacturer - Part 3: Instruments for professional use (ISO/CD 18113-3:2006) | Under development |
prEN ISO 18113-4 | In vitro diagnostic medical devices - Information supplied by the manufacturer - Part 4: Reagents for self-testing (ISO/CD 18113-4:2006) | Under development |
prEN ISO 18113-5 | In vitro diagnostic medical devices - Information supplied by the manufacturer - Part 5: Instruments for self-testing (ISO/CD 18113-5:2006) | Under development |
prEN ISO 20795-1 | Dentistry - Base polymers - Part 1: Denture base polymers | Under development |
prEN ISO 20795-2 | Dentistry - Base polymers - Part 2: Orthodontic base polymers | Under development |
prEN ISO 21531 | Dentistry - Graphical symbols | Under approval |
prEN ISO 21549-7 | Health informatics - Patient healthcard data - Part 7: Electronic prescription (medication data) (ISO/DIS 21549-7:2004) | Under approval |
prEN ISO 21606 | Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO/DIS 21606:2006) | Under approval |
prEN ISO 22674 | Dentistry - Metallic materials for fixed and removable dental restorations and appliances (ISO/FDIS 22674:2006) | Under approval |
prEN ISO 22871 | Dentistry - Zinc oxide-eugenol dental impression paste | Under development |
USA
Association for the Advancement of Medical Instrumentation (AAMI)/ American National Standards Institute (ANSI)
Number | Title | Notes |
ANSI/AAMI/IEC 62304, Ed.1-2006 | Medical device software - Software life-cycle processes | Identical national adoption and revision of ANSI/AAMI SW68-2001). Effective 17 July 2006 |
BSR/AAMI/IEC 62366-200x | Medical devices - Application of usability engineering to medical devices | National adoption with modifications and revision of ANSI/AAMI HE74-2001. Comments due by 19 September 2006 |
BSR/AAMI/ISO 10993-14-2001 (R200x) | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics | Reaffirmation of ANSI/AAMI/ISO 10993-14-2001. Comments due by 10 October 2006 |
BSR/AAMI/ISO 10993-15-2000 (R200x) | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys | Reaffirmation of ANSI/AAMI/ISO 10993-15-2000. Comments due by 10 October 2006 |
BSR/AAMI/ISO 15223/A1-200x | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - Amendment 1 | Supplement to ANSI/AAMI/ISO 15223-1-200x. Comments due by 17 October 2006 |
BSR/AAMI/ISO 15223-2-200x | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol validation | Identical national adoption. Comments due by 17 October 2006 |
BSR/AAMI PC69, Ed.2.200x | Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators | Revision of ANSI/AAMI PC 69-2000. Comments due by 17 October 2006 |
BSR/ADA 13-1981 (R200x) | Dental Cold Curing Repair Resins | Reaffirmation of ANSI/ADA 13-1981 (R1999). Comments due by 2 October |
BSR/ADA 17-1983 (R200x) | Denture Base Temporary Relining Resins | Reaffirmation of ANSI/ADA 17-1983 (R1999). Comments due by 2 October 2006 |
BSR/ADA 26-1991 (R200x) | Dental X-ray Equipment & Accessory Devices | Reaffirmation of ANSI/ADA 26-1991 (R1999). Comments due by 2 October 2006 |
BSR/ADA 32-200x | Orthodontic Wires | Identical national adoption and revision of ANSI/ADA 32-2000. Comments due by 2 October 2006 |
BSR/ADA 44-1979 (R200x) | Dental Electrosurgical Equipment | Reaffirmation of ANSI/ADA 44-1979 (R1999). Comments due by 2 October 2006 |
BSR/ADA 47-200x | Dental Units | National adoption with modifications and revision of ANSI/ADA 47-1983 (R2003). Comments due by 2 October 2006 |
BSR/ADA 57-2000 (R200x) | Endodontic Sealing Materials | Reaffirmation of ANSI/ADA 57-2000. Comments due by 2 October 2006 |
BSR/ADA 63-200x | Root Canal Barbed Broaches and Rasps | Revision of ANSI/ADA 63-1999. Comments due by 2 October 2006 |
BSR/ADA 88-2000 (R200x) | Dental Brazing Alloys | Reaffirmation of ANSI/ADA 88-2000. Comments due by 2 October 2006 |
BSR/ADA 109-200x | Procedures for Storing Dental Amalgam Waste and Requirements for Amalgam Waste Storage/Shipment Containers | Comments due by 2 October 2006 |
BSR/ADA 1000-2001 (R200x) | Standard Clinical Architecture for the Structure and Content of an Electronic Health Record | Reaffirmation of ANSI/ADA 1000-2001. Comments due by 16 October 2006 |
BSR/ADA 1001-2002 (R200x) | Guidelines for the Design of Educational Software | Reaffirmation of ANSI/ADA 1001-2002. Comments due by 16 October 2006 |
BSR/HL7 EHR, R1-200x | HL7 EHR System Functional Model, Release 1 | Comments due by 25 September 2006 |
BSR/HL7 V3 MR, R1-200x | HL7 Version 3 Standard: Medical Records/Information Management, Release 1 | Comments due by 25 September 2006 |