YY 0504-2016Portable mode steam sterilizers (English PDF)

Foreword

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

This standard replaces YY 0504-2005 "Portable Steam Sterilizer". This standard compared with YY 0504-2005, the main technical changes as follows.

--- Increased supply of sterilizer supply (see 5.1.2);

- the technical requirements for the addition of the seal of the sterilization chamber cap (see 5.2.3);

- to increase and modify the specific requirements for the sterilization of the sterilizer (see 5.3, 2005 edition 5.12);

--- Increased requirements for sterilizer materials (see 5.4);

- Increased technical requirements for sterile loading attachments (see 5.10);

- The sterilization temperature is specified as specified by the manufacturer, the lower limit is the sterilization temperature, and the upper limit is the sterilization temperature 3 ° C (see 5.12, 2005 Version 5.8);

--- Increased sterilizer alarm indication (see 5.14);

- modified environmental testing requirements (see 5.19, 2005, 5.14);

- Modification of the sterilization test method (see 6.16, Appendix B, 2005 Edition 6.13);

- the inspection classification was deleted (2005 version 7.1);

--- Increased supply of water quality indicators (see Appendix A).

1 Scope

This standard specifies the terminology and definition, classification, structure and basic parameters of the portable steam sterilizer, requirements, test methods, inspection rules, Logo and instructions and packaging, transportation and storage.

This standard applies to the sterilization temperature of not more than 132 °C portable steam sterilizer (hereinafter referred to as sterilizer).

2 Normative reference documents

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

GB 150 (all parts) pressure vessel

GB/T 191 packaging and storage icon

GB/T 1226 general pressure gauge

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements General rules for the use of industrial products GB/T 9969 Environmental requirements and test methods for medical appliances GB/T

GB 18281.3 Sterilization products for health care products - Part 3. Biological indicators for damp heat sterilization GB/T 19971 Sterilization terminology for health care products

YY 0154 Springs for steam sterilization equipment Standard type spring valves for pressure steam sterilization equipment YY/T 0157

IEC 61010-2-040.:2005 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040. Procedures for the treatment of medical equipment With the special requirements of sterilizers and cleaning sterilizers (Safetyrequirementsforelectricalequipmentformeasure-ment, controlandlaboratoryuse-Part 2-040. Particularrequirementsforsterilizersandwasher-disin-fectorsusedtotreatmedicalmaterials

3 Terms and definitions

The terms and definitions defined in GB/T 19971 apply to this document.

4 Classification, structure and basic parameters