医疗器械CE认证分类.docVIP

MEDDEV 2.4/1 – rev. 8 PART 2: GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES (July 2001) 医疗器械分类指导方针（2001年7月） ................. 4.2 GENERAL EXPLANATION OF RULES/PRACTICAL ISSUES/EXAMPLES 规则、实际问题、举例简介 Rule 1 -Devices that either do not touch the patient or contact intact skin only 规则1- 不与病人接触或仅仅接触皮肤的器械 General explanation of the rule 规则简介 This is a fallback rule applying to all devices that are not covered by a more specific rule.This is a rule that applies in general to devices that come into contact only with intact skin or that do not touch the pa