This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure.<\/p>\n
This document provides high-level requirements and respective test methods that are general in nature.<\/p>\n
This document does not provide quantitative requirements for process parameters or parameters of the sterilization cycle, or requirements for performance testing, validation or routine control of sterilizers because these depend on the respective sterilization method.<\/p>\n
This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof.<\/p>\n
This document does not apply to:<\/p>\n
sterilizers using radiation as the sterilizing agent;<\/p>\n<\/li>\n
sterilizers for laboratory equipment;<\/p>\n<\/li>\n
sterilizers used to prepare culture media;<\/p>\n<\/li>\n
sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category;<\/p>\n<\/li>\n
systems used for bio-decontamination of rooms and isolator systems;<\/p>\n<\/li>\n
systems used for sterilization in place; or<\/p>\n<\/li>\n
washer-disinfectors.<\/p>\n<\/li>\n<\/ul>\n
Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.<\/p>\n<\/div>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4 General 4.1 Product definition 4.2 Equipment development <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 4.3 Calibration 5 Equipment design and construction 5.1 Safety and security <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2 Chamber 5.2.1 Dimensions 5.2.2 Doors <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.2.3 Chamber integrity 5.2.4 Pressure vessels 5.2.5 Uniformity of conditions 5.2.6 Ancillary equipment and components 5.3 Materials <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.4 Interlocks 5.5 Test connections <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.6 Vibration 5.7 User interfaces <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 6 Indicating, monitoring, controlling and recording 6.1 General 6.2 Automatic control <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 6.3 Control and monitoring system <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 6.4 Failure 6.4.1 General <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.4.2 Fault 6.4.3 Power failure 6.4.4 Other failures <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 6.5 Instrumentation <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 6.6 Indicating devices <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.7 Recorders <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 7 Services and local environment 7.1 General 7.2 Sterilizing agent and sterilant 7.3 Electrical supply 7.4 Water <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 7.5 Steam 7.6 Vacuum 7.7 Drains 7.8 Lighting <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 7.9 Compressed air 7.10 Air and inert gases 7.11 Ventilation 8 Emissions 8.1 Electromagnetic emissions 8.2 Noise <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 8.3 Exhaust emissions 8.4 Heat emission <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 9 Test instrumentation <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 10 Performance and assessment 10.1 General 10.2 Chamber integrity <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 10.3 Attainment of conditions 10.4 Microbiological performance 10.5 Pressure change 11 Information supplied by the manufacturer 11.1 General <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 11.2 Information to be made available prior to purchase 11.3 Marking 11.4 Label <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 11.5 Instructions for use <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 11.6 Technical description <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex A (informative) Rationale for requirements <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Annex B (informative) Illustrations of the interrelationship between control and recording <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities<\/b><\/p>\n |