YY/T 0615.1-2007Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices (English PDF)
标示无菌医疗器械的要求第1部分:最终灭菌医疗器械的要求
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Issued by
State Food and Drug Administration
Level / Type
Industry · Recommended
Issue date
July 2, 2007
Implementation date
March 1, 2008
Scope
YY/T 0615.1-2007 is the English-translated version of 标示无菌医疗器械的要求第1部分:最终灭菌医疗器械的要求.
YY/T 0615.1-2007 is the Chinese standard "Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices".
Its scope clause reads: YY/T 0615 provisions of this part of the declaration of "sterile" terminally sterilized medical devices requirements. YY/T 0615 Part 2 sets out Labeled "sterile" medical instruments sterile processing requirements.
Note. When using a medical device only confirmed a sterilization process, it may be declared "sterile." GB 18278, GB 18279, GB 18280, GB/T 19974, ISO 14160 provides for medical device sterilization validation and routine control. Its clauses include terms and definitions.
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Document preview — YY/T 0615.1-2007
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C 47
Issued by: State Food and Drug Administration
Contents
- Foreword
- Introduction
- 1 Scope
1 Scope
YY/T 0615 provisions of this part of the declaration of "sterile" terminally sterilized medical devices requirements. YY/T 0615 Part 2 sets out
Labeled "sterile" medical instruments sterile processing requirements.
Note. When using a medical device only confirmed a sterilization process, it may be declared "sterile." GB 18278, GB 18279, GB 18280,
GB/T 19974, ISO 14160 provides for medical device sterilization validation and routine control.
2 Normative references
The following documents contain provisions which, through YY/T 0615 reference in this text, constitute provisions of this part. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT)
3 Terms and Definitions
The following terms and definitions apply YY/T 0615 of this section.
3.1
Product and/or packaging of the number of viable microorganisms.
3.2
Designed by the manufacturer to become the following purposes for the human body, whether used alone or in combination, including the use of the required software
Any instrument within the apparatus, appliances, materials or other items, in order to.
--- Diagnosis, prevention, monitoring, treatment or alleviation;
--- Disability diagnosis, monitoring, treatment, mitigation or compensation;
--- Body structure or physiological process of research, replace or repair;
--- Pregnancy control.
For the human body or its principal expected effect on the human body is not a pharmacological, immunological or metabolic means to obtain, but in these instruments
It uses play a supporting role.
3.3
No viable microorganisms state.
3.4
A medical device no viable microorganisms situation.
3.5
Medical devices after packaging or assembly through a sterilization process and maintaining the device or which particular part in sterility […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
Cited by
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Related Standards
YY/T 0287-2003 — Medical devices - Quality management systems - Requirements for regulatory purposes
YY/T 0615.2-2007 — Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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