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BSI PD ISO/TS 22421:2021

BSI PD ISO/TS 22421:2021

$198.66

Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Published By Publication Date Number of Pages
BSI 2021 56
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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.

This document provides high-level requirements and respective test methods that are general in nature.

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.

This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof.

This document does not apply to:

  • sterilizers using radiation as the sterilizing agent;

  • sterilizers for laboratory equipment;

  • sterilizers used to prepare culture media;

  • sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category;

  • systems used for bio-decontamination of rooms and isolator systems;

  • systems used for sterilization in place; or

  • washer-disinfectors.

NOTE

Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
10 1 Scope
2 Normative references
11 3 Terms and definitions
21 4 General
4.1 Product definition
4.2 Equipment development
22 4.3 Calibration
5 Equipment design and construction
5.1 Safety and security
23 5.2 Chamber
5.2.1 Dimensions
5.2.2 Doors
24 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
25 5.4 Interlocks
5.5 Test connections
26 5.6 Vibration
5.7 User interfaces
27 6 Indicating, monitoring, controlling and recording
6.1 General
6.2 Automatic control
28 6.3 Control and monitoring system
29 6.4 Failure
6.4.1 General
30 6.4.2 Fault
6.4.3 Power failure
6.4.4 Other failures
31 6.5 Instrumentation
32 6.6 Indicating devices
33 6.7 Recorders
34 7 Services and local environment
7.1 General
7.2 Sterilizing agent and sterilant
7.3 Electrical supply
7.4 Water
35 7.5 Steam
7.6 Vacuum
7.7 Drains
7.8 Lighting
36 7.9 Compressed air
7.10 Air and inert gases
7.11 Ventilation
8 Emissions
8.1 Electromagnetic emissions
8.2 Noise
37 8.3 Exhaust emissions
8.4 Heat emission
38 9 Test instrumentation
39 10 Performance and assessment
10.1 General
10.2 Chamber integrity
40 10.3 Attainment of conditions
10.4 Microbiological performance
10.5 Pressure change
11 Information supplied by the manufacturer
11.1 General
41 11.2 Information to be made available prior to purchase
11.3 Marking
11.4 Label
42 11.5 Instructions for use
43 11.6 Technical description
45 Annex A (informative) Rationale for requirements
48 Annex B (informative) Illustrations of the interrelationship between control and recording
54 Bibliography

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BSI PD ISO/TS 22421:2021
$198.66