US FDA revises list of recognised medical device standards

The US Food and Drug Administration has outlined changes to its list of recognised medical device standards that came into effect on 16 March. The updated list (number 028) is expected to help manufacturers who decide to declare conformity with consensus standards meet certain requirements for medical devices¹.

The changes are outlined in a Federal Register notice. They comprise the withdrawal of standards and their replacement by others, the correction of errors made by the FDA in listing previously recognised standards and the changes to the supplementary information sheets of recognised standards that describe revisions to the applicability of the standards. They also comprise new standards not previously recognised by the FDA.

Some of the new entries include:

• ANSI/AAMI/ISO 14155:2011: Clinical investigation of medical devices for human subjects—Good clinical practice;
• ISO 14155 Second edition 2011–02–01: Clinical investigation of medical devices for human subjects—Good clinical practice;
• ISO 14155: 2011 Technical Corrigendum 1 Published 2011–07–15: Clinical investigation of medical devices for human subjects—Good clinical practice, Technical Corrigendum 1;
• ANSI/AAMI/ISO 15223–2:2010: Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation;
• IEC 60601–1–11 (First edition – 2010) April 2011: Medical electrical equipment – Part 1–11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Corrigendum 1;
• ANSI/AAMI/ISO 14971:2007/(R)2010: ANSI/AAMI/ISO 14971:2007/(R)2010;
• CLSI GP26–A4: Quality Management System: A Model for Laboratory Services; Approved Guideline – Fourth Edition;
• CLSI M53–A: Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline;
• ANSI/AAMI/ISO 14708–3:2008: Implants for surgery – Active implantable medical devices Part 3: Implantable neurostimulators;
• ISO 7207–1 Third edition 2007–02–01: Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions;
• ASTM F732 – 00 (Reapproved 2011): Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses;
• IEC 62274 First edition 2005–05: Medical electrical equipment – Safety of radiotherapy record and verify systems;
• ISO 11737–2 Second edition 2009–11–15: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; and
• ISO 81060–1 First edition 2007–12–01: Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type.

The FDA maintains an updated list of all recognised consensus standards in an online searchable database. The latest modifications will also be incorporated into the database.

References

1. Federal Register, 16 March 2012, 77(52), 15765-15779, www.gpo.gov/fdsys/pkg/FR-2012-03-16/pdf/2012-6389.pdf