APPENDIX A

IDSC Standards and Practices Year 2006 Edition

HTM 2010: Health Technical Memorandum No. 20/10 1994-1997 sterilizers
Parts 1-6 (HMSO).

HBN 13: Health Building Note No. 13 Design considerations for Sterile
Service Departments (HMSO).

ISO 13485: 2003 Medical Devices – Quality Management Systems – Systems
Requirements for Regulatory Purposes.

HTM 2030:  Health Technical Memorandum No. 2030 1997 Washer
Disinfectors Parts 1-3 (HMSO)

HTM 2031:  Health Technical Memorandum No. 2031 1997 Clean Steam for
Sterilization (HMSO)

Official Journal of the European Communities L 169 - Council Directive
93/42/EEC of 14 June 1993 concerning medical devices

BS EN ISO 14644 – 1: Clean Rooms and Associated Controlled Environments
- Classification of Air Cleanliness

BS EN ISO 14644 – 2: Clean Rooms and Associated Controlled Environments
- Specification for Testing and Monitoring to Prove Continued Compliance
with BS EN ISO 14644 - 1