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YY/T 1609-2018Cassette steam sterilizer (English PDF)

卡式蒸汽灭菌器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 26, 2018

Implementation date

July 1, 2019

Scope

YY/T 1609-2018 is the English-translated version of 卡式蒸汽灭菌器.

YY/T 1609-2018 is the Chinese pharmaceutical industry standard for the cassette steam sterilizer, the small automatically controlled autoclave with an electrically heated steam supply and a chamber of no more than 10 L. It sets the normal working conditions, the requirements and the test methods, covering the temperature and pressure of the cycle and their accuracy, the air removal, the cassette and its sealing, the cycle indication and records, the safety devices and the electrical safety. Issued on 26 June 2018, it has applied since 1 July 2019.

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Document preview — YY/T 1609-2018

National Standard of the People's Republic of China

ICS: 11.080.10
Classification: C 47

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 normal working conditions
5 Requirements
6 Test method
Appendix A (informative) Comparison with YY/T 0646-2015
Appendix B (Normative Appendix) Test Method for Sterilization Effect

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the normal working conditions, requirements, test methods, etc. of the card steam sterilizer.

This standard is applicable to the automatic control type of steam generated by electric heating, and the small-sized steam sterilizer of the sterilization chamber has a volume of not more than 10L. (hereinafter referred to as sterilizer).

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 18281.1 Sterilization of biological indicators for health care products - Part 1. General (GB 18281.1-2015, ISO 11138- 1.2006, IDT)

GB 18281.3 Sterilization of biological indicators for health care products - Part 3. Biological indicators for moist heat sterilization (GB 18281.3- 2015, ISO 11138-3:2006, IDT)

GB/T 19971 Terminology of sterilization of health care products (GB/T 19971-2015, ISO /T S11139.2006, IDT)

YY/T 0158 Gasket for pressure steam sterilization equipment

YY/T 0646-2015 Small steam sterilizer automatic control type

END/T 0698.5-2009 Terminals for medical devices - Part 5. s.

Combination bag and coil requirements and test methods Plastics and packaging materials for terminal sterilizing - Part 8. Res. Requirements and test methods

YY/T 1402-2016 Test method for suitability of medical device steam sterilization process challenge device TSG21-2016 Safety Regulations for Fixed Pressure Vessels Disinfection Technical Specification (2002 Edition)

3 Terms and definitions

The following terms and definitions as defined in GB/T 19971, YY/T 0646-2015 apply to this document.

3.1 Cassette steam sterilizer

The saturated steam generated by electric heating is used as a sterilization medium, and the sterilization chamber has a cassette structure, the volume is not more than 10L, and the sterilization can be completed. Remove the sterilizer from the cartridge.

3.2 Sterilization cassette cassette

A part of the card steam sterilizer that can be withdrawn from the sterilization chamber.

4 Normal working conditions

The sterilizer works normally under the following conditions.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

GB 18281.1 · GB 18281.3

Similar standards

GB/T 30690-2026|YY 1277-2023|GB/T 30690-2014

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