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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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YY 91083-1999

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