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YY 1275-2016Dry heat (heated air) sterilizers (English PDF)

热空气型干热灭菌器

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 23, 2016

Implementation date

January 1, 2018

Scope

YY 1275-2016 is the English-translated version of 热空气型干热灭菌器.

YY 1275-2016 is the Chinese standard "Dry heat (heated air) sterilizers". Its scope clause reads: This standard specifies the terms and definitions of hot air dry heat sterilizers, requirements, test methods, inspection rules and signs, packaging, use Brochures, transportation and storage.

This standard applies to convective hot air as a sterilization medium for dry heat sterilizer (hereinafter referred to as sterilizer). The sterilizer is mainly used for experiments Indoor, nursing clinics, hospitals and other medical establishments and their accessories.

This standard does not apply to conductive or radiant dry heat sterilizers, does not specify the safety requirements related to the use of the risk range, does not require dry heat (Hot air) sterilization confirmation and routine control and dry heat pyrogen removal requirements. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY 1275-2016

National Standard of the People's Republic of China

ICS: 11.080.10
Classification: C47

Issued by: National Medical Products Administration

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 classification and basic parameters
5 request
6 Test Method
7 Inspection rules
8 mark, instruction manual, packing, transportation, storage
Appendix A (normative) Temperature sensor arrangement
Appendix B (informative) Requirements for sterilizers for sterilizers

1 Scope

This standard specifies the terms and definitions of hot air dry heat sterilizers, requirements, test methods, inspection rules and signs, packaging, use

Brochures, transportation and storage.

This standard applies to convective hot air as a sterilization medium for dry heat sterilizer (hereinafter referred to as sterilizer). The sterilizer is mainly used for experiments

Indoor, nursing clinics, hospitals and other medical establishments and their accessories.

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 article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191 Packaging and Storage Icons (GB/T 191-2008, ISO 780..1997, MOD)

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (GB 4793.1-2007,

IEC 61010-1..2001, IDT)

GB/T 4982 Vacuum technology - Quick release connector dimensions - Part 1. Clamping type [GB/T 4982-2003, ISO 2861-1. 1974 (E), IDT]

Environmental requirements and test methods for medical appliances GB/T 14710-2009

GB/T 18268 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use (GB/T 18268-2000, IEC 61326-

1-1997, IDT)

YY/T 0466.1-2016 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General purpose (ISO 15223-1..2007, IDT)

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

Disinfection technical specifications of the People's Republic of China Ministry of Health (2002 edition)

3 terms and definitions

The following terms and definitions apply to this document.

3.1 Hot air heat dry sterilization dryHeat (heatedair) sterilize

Use convective hot air as a sterilization medium for sterilization.

3.2 Hold time holdingtime

Sterilization chamber reference measurement point and the temperature of each part are kept in the sterilization temperature range.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 29 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 780 · IEC 61010 · ISO 2861 · GB/T 18268-2000 · IEC 61326 · ISO 15223

Cited by

YY/T 1478-2016Traceability information of disinfection and sterilization reusable medical devices

Similar standards

YY/T 1268|YY 1277|YY/T 1302.2

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