Standard No.:	YY 0068.3-2008
English Name:	Medical endoscopes—Rigid endoscope—Part 3:Marking and instruction manual
Chinese Name:	医用内窥镜 硬性内窥镜 第3部分：标签和随附资料
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Administration
Issued on:	2008-10-17
Implemented on:	2010-6-1
Status:	valid
Superseding:	YY 0068-1992 General specification for medical rigid endoscopes
Language:	English
File Format:	PDF
Word Count:	6000 words
Price(USD):	140.0
Delivery:	via email in 1 business day

1 Scope This part of YY 0068 specifies the requirements for marking and instruction manual of rigid endoscope. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0068. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part. However parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. GB 9706.19 Medical Electrical Equipment — Rigid Endoscope — Part 2: Particular Requirements for the Safety of Endoscopic Equipment (GB 9706.19-2000, idt IEC 60601-2-18:1996) YY 0068.1 Medical Endoscopes — Rigid Endoscope — Part 1: Optical Properties and Test Methods YY 0068.2 Medical Endoscopes — Rigid Endoscope — Part 1: Mechanical Properties and Test Methods ISO 10526:1999 CIE S 005 CIE Standard Illuminants for Colorimetry 3 Requirements 3.1 Marking 3.1.1 Minimum marking

Foreword II 1 Scope 2 Normative References 3 Requirements Annex A (Informative) Examples of Instruction Manual