YY 91083-1999Fiber optic cystoscope (English PDF)
纤维导光膀胱镜
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
May 15, 1989
Implementation date
January 1, 1990
Scope
YY 91083-1999 is the English-translated version of 纤维导光膀胱镜.
YY 91083-1999 is a mandatory Chinese medical device standard for fibre optic cystoscopes. It sets the product classification, the technical requirements and the test methods, and it adds the inspection rules along with marking, packaging, transport and storage.
The instruments covered are rigid fibre optic cystoscopes, used to examine the cavity of the bladder and to support urography and surgical work. Among the documents it calls on are GB 191, GB 1185, GB 2270, GB 2828, GB 2829, ZB C40002, YB 717, WS 2-1 and WS 2-283.
It took the place of ZB C40005-1989. Issued on 15 May 1989, it has applied since 1 January 1990.
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Document preview — YY 91083-1999
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- [Preview only]
- 1 Scope
- 2 Normative References
- 2.1 Terms
- 3 Terms and Definitions
- 4 Overview
- 4.1 General requirements
- 5 Technical Requirements
- 6 Calibration conditions
- 6.1 Environmental conditions
- 6.2 Measurement standards and other equipment
- 7 Calibration items and calibration methods
- 7.1 Calibration Items
- 7.2 Calibration method
- 8 Expression of calibration results
- 9 Recalibration interval
1 Foreword
YY 91083-1999 was issued by National Medical Products Administration of the People's Republic of China on 15 May 1989.
The YY prefix, without a suffix, marks a mandatory standard: within its scope, compliance is required.
The document runs to 15 pages in English translation.
2 Scope Preview
This standard is a mandatory Chinese medical device standard for fibre optic cystoscopes. It sets the product classification, the technical requirements and the test methods, and it adds the inspection rules along with marking, packaging, transport and storage. The instruments covered are rigid fibre optic cystoscopes, used to examine the cavity of the bladder and to support urography and surgical work. Among the documents it calls on are GB 191, GB 1185, GB 2270, GB 2828, GB 2829, ZB C40002, YB 717, WS 2-1 and WS 2-283. It took the place of ZB C40005-1989.
YY 91083-1999 carries no ICS number and no Chinese Standard Classification code.
This catalogue holds 943 other YY standards.
Of the 199 YY standards that do carry an ICS number, 198 (99%) fall under ICS 11, in the field of health care technology.
3 Normative references
GB 191
GB 1185
GB 2270
GB 2828
GB 2829
YB 717
WS 2-1
WS 2-283
4 About this standard
Issued by: National Medical Products Administration of the People's Republic of China
English translation: about 15 pages
5 Related standards
Standards on related subjects:
YY/T 1876-2023 — Tissue engineered medical products - Quantification of remnant DNA in animal-derived biomaterials - Fluorescent staining method
YY 9706.258-2022 — Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
YY 9706.257-2021 — Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic or aesthetic use
YY/T 1878-2023 — Technical requirements for digitization of positron emission tomography equipment
YY/T 1028-2023 — Medical endoscopes - Fibre endoscopes
6 Classification and status
Chinese Standard Classification (CCS): C 40
Prefix YY: mandatory standard.
......
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
GB 1185 · GB 2270 · GB 2828 · GB 2829 · YB 717 · WS 2-1 · WS 2-283
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