YY/T 0068.3-2008Medical endoscopes - Rigid endoscopes - Part 3: Marking and instruction manual (English PDF)
医用内窥镜 硬性内窥镜 第3部分：标签和随附资料
Open the YY/T 0068.3-2008 preview as PDF
This is a limited preview
Buy now to download the full PDF (15 pages)
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY/T 0068.3-2008 is the English-translated version of 医用内窥镜 硬性内窥镜 第3部分：标签和随附资料.
YY/T 0068.3 sets what has to be marked on a rigid endoscope and what has to be in the manual that comes with it. It sounds administrative and is not: the marking is how a nurse in a sterile processing department knows which reprocessing cycle an instrument tolerates, and how a surgeon picks the right angle of view from a tray of scopes that look alike. The manual is where the manufacturer states the cleaning and sterilization methods that have been validated, the inspection that detects damage, and the limits of use. Reprocessing failures in endoscopy have caused documented outbreaks, and they usually trace back to instructions that were unclear or not followed. This is Part 3 of the Chinese rigid endoscope series and the text a registration dossier's labelling section is checked against.
Document preview — YY/T 0068.3-2008
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 17 October 2008 by the National Medical Products Administration and takes effect on 1 June 2010.
It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.
1 Scope
YY/T 0068.3 sets what has to be marked on a rigid endoscope and what has to be in the manual that comes with it. It sounds administrative and is not: the marking is how a nurse in a sterile processing department knows which reprocessing cycle an instrument tolerates, and how a surgeon picks the right angle of view from a tray of scopes that look alike. The manual is where the manufacturer states the cleaning and sterilization methods that have been validated, the inspection that detects damage, and the limits of use. Reprocessing failures in endoscopy have caused documented outbreaks, and they usually trace back to instructions that were unclear or not followed. This is Part 3 of the Chinese rigid endoscope series and the text a registration dossier's labelling section is checked against.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
How to Buy YY/T 0068.3-2008
- 1Add to cart. Click the "Buy YY/T 0068.3-2008" button on this page. You can add more standards before checkout.
- 2Checkout. Enter your email and billing details. Payment is processed securely by Stripe (cards, Apple Pay, Google Pay supported).
- 3Instant delivery (0–9 sec). Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4Invoice included. A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0492-2026 — Implantable leads
YY/T 0517-2026 — Dentistry - Posts
Secure payment via Stripe
Payments accepted
YY/T 0068.3-2008
$155.00