1 Scope
This standard specifies application scope, definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of slit-lamp microscope.
This standard is applicable to slit-lamp microscope for the inspection of lesion of anterior segment and intraocular part.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending errors in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies.
GB/T 191-2000 Packaging - Pictorial Marking for Handling of Goods
GB/T 2828.1-2003 Sampling Procedures for Inspection by Attribute – Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (idt ISO 2859-1:1999)
GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection Of Process Stability)
GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (idt IEC 601-1:1988)
GB 9969.1-1998 General Principles for Preparation of Instructions for Use of Industrial Products
GB/T 14710-1993 The Environmental Requirements and Test Methods for Medical Electrical Equipment
GB/T 10050-1988 Optics and Optical Instruments - Reference Wavelengths
3 Terms and Definitions
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Inspection Rules
7 Marks, Labels and Operating Instructions
8 Packing, Transportation and Storage
