This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
Số hiệu tiêu chuẩn
DS/EN 15986
Tên tiêu chuẩn
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Ngày phát hành
2011-04-14
Tiêu chuẩn tương đương
IDTEN 15986:2011, IDT
Từ khóa
DEFINITIONS * GRAPHIC REPRESENTATION * GRAPHIC SYMBOLS * INFORMATION * LABELLING * MARKING * MEDICAL DEVICES * MEDICAL EQUIPMENT * MEDICAL INSTRUMENTS * MEDICAL SCIENCES * MEDICAL TECHNOLOGY * PHTHALATES * PHTHALIC ACID * PLASTICIZERS * SPECIFICATION (APPROVAL) * SYMBOLS * MEDICAL PRODUCTS * DEFINITION * Graphic symbols * Medical devices * Medical technology * Marking * Specification (approval) * Phthalic acid * Labelling * Medical equipment * Medical instruments * Phthalates * Medical products * Medical sciences * Symbols * Information * Definitions * Graphic representation * Plasticizers
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