YY/T 0646-2022Small steam sterilizers (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document replaces YY/T 0646-2015 "Small pressure steam sterilizer automatic control type", compared with YY/T 0646-2015, In addition to structural adjustments and editorial changes, the main technical changes are as follows.

--- Changed the standard scope (see Chapter 1, Chapter 1 of the.2015 edition);

--- Changed normative references (see Chapter 2, Chapter 2 of the.2015 edition);

--- Changed terms and definitions (see Chapter 3, Chapter 3 of the.2015 edition);

--- Changed the type of sterilization cycle (see Chapter 4, Chapter 4 of the.2015 edition);

--- Deleted normal working conditions (see 5.1.1 of the.2015 edition);

--- Changed the requirements for the appearance, structure and size of the sterilization chamber (see 5.2, 5.2 of the.2015 edition);

--- Changed the requirements for pressure vessels (see 5.3.1, 5.3.1 of the.2015 edition);

--- Changed the requirements for doors and interlocking devices (see 5.3.3, 5.3.3 of the.2015 edition);

--- Changed the requirements for air filters (see 5.3.5, 5.3.5 of the.2015 edition);

--- Delete the requirements for safety valves, steam traps and pressure reducing valves (see 5.3.6, 5.3.7, 5.3.8 of the.2015 edition);

--- Changed the requirements for the instrument (see 5.4.2, 5.4.2 of the.2015 edition);

--- Changed the requirements for acoustic signals (see 5.4.3.3, 5.4.3.3 of the.2015 edition);

--- Changed the requirements for recording devices and records (see 5.4.4, 5.4.4 of the.2015 edition);

--- Change the requirements for saturated steam temperature and time (see 5.11, 5.11 of the.2015 edition);

--- Increased test water condition requirements (see 6.1.1);

--- Deleted the test method for the factory inspection or installation inspection process (see 6.11.4.2.2, 6.11.5.3, 6.11.6.3 of the.2015 edition);

--- Deleted the test method for factory inspection (see 7.3 of the.2015 edition);

--- Deleted the test method for installation inspection (see 7.4 of the.2015 edition);

--- Changed the inspection items (see 7.3, see 7.5 of the.2015 edition);

--- Deleted the requirements for signs and instructions for use (see Chapter 8 of the.2015 edition);

--- Delete the requirements for packaging, transportation and storage (see Chapter 9 of the.2015 edition);

--- Deleted the relevant specification of the simplified test package (see E.1.2.2 of the.2015 edition).

1 Scope

This document specifies the sterilization cycle types, requirements, test methods and inspection rules for small pressure steam sterilizers (hereinafter referred to as sterilizers).

This document applies to steam generated by electric heating or external steam, the side opening of the sterilization chamber, the volume is less than 60L, and a sterilizer cannot be loaded.

The bacteria unit (300mmx300mmx600mm), the rated working pressure is not more than 0.25MPa and the preset sterilization temperature is 115°C~ Automatically controlled small pressure steam sterilizer in the range of 138°C.

Note. The pressure mentioned in this document refers to gauge pressure unless indicated as absolute pressure.

This document does not apply to vertical pressure steam sterilizers, portable pressure steam sterilizers, cassette steam sterilizers and liquid sterilization.

This document does not specify safety requirements involving the scope of use risk, nor does it specify requirements for validation and routine control of moist heat sterilization.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB 4793.4 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 4: Sterilizers for Handling Medical Materials and special requirements for washer-disinfectors

GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances

GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB 18281.1 Biological Indicators for Sterilization of Healthcare Products Part 1: General

GB 18281.3 Biological Indicators for Sterilization of Healthcare Products Part 3: Biological Indicators for Moist Heat Sterilization

GB 18282.1 Sterilization Chemical Indicators for Healthcare Products Part 1: General GB/T.19971 Terms for Sterilization of Healthcare Products GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices general requirements

YY/T 0698 (all parts) Packaging materials for terminally sterilized medical devices

3 Terms and Definitions GB/T.19971 and the following

terms and definitions apply to this document.