Iso 15223 1 pdf

Iso 15223 1 pdf

Rating: 4.5 / 5 (2925 votes)

Downloads: 98031

CLICK HERE TO DOWNLOAD

.

.

.

.

.

.

.

.

.

.

1 fragile, handle with care refers to a medical device that can break or become damaged if carelessly handled. iso标准（ medical devices — symbols to be used with information to be supplied by the manufacturer — part 1: general iso 15223 1 pdf requirements） 规定了用于表达医疗设备提供信息的标识， 适用于广泛的医疗器械中使用的标识。 这些标识可用于医疗器械本身、 包装或随附信息中。. designator of legally binding document: is/ isotitle of legally binding document: medical devices - symbols to be used with medical device labels, labelling and information to be supplied, part 1: general requirements number of amendments: equivalence: iso: superceding: superceded by: legally binding document. contains hazardous substances 5. iso 3166- 1, codes for the representation of names of countries and their subdivisions — part 1: country code iso 8601- 1, date and time — representations for information interchange — part 1: basic rules iso 8601- 2, date and time — representations for information interchange — part 2: extensions iso, medical devices — symbols. medical device 2. 1] iso 3864- 1, graphical symbols — safety colours and safety signs — part 1: design principles for safety signs and safety markings [ 2] iso 7010, graphical symbols — safety colours and safety signs — registered safety signs [ 3] iso 14971, medical devices — application of risk management to medical devices [ 4]. iso: ( e) note 3 to entry: accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types ( e. this corrected version of iso: incorporates the following correction: — in a. this document specifies symbols used to express information supplied for a medical device. for information on use of symbols mentioned in the present document iso: should be consulted. language; std 1 173: pdf + epub: std 2 173: paper: chf 173; add to cart; convert swiss francs ( chf) to your currency. standard: iso, medical devices - symbols 5. this part of iso 15223 constitutes a technical revision of both iso: and en 980:, combining the symbols and requirements of both standards for the first time. in accordance with adobe' s licensing policy, this file may be printed or viewed but. 3 non- pyrogenic indicates a medical device that is non- pyrogenic. note future symbols intended to appear in this document are to be validated in accordance with iso. contains a medicinal substance 4. 1) without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people. there has been a steady convergence of the symbol requirements in isoand en 980 over recent years, with many of the. this fourth edition cancels and replaces the third edition ( iso: ), which has been technically revised. 3) and/ or associated documentation of a medical device that communicates characteristic information ( 3. 9, the graphical symbol of note 2 has been corrected. graphical representation appearing on the label ( 3. the present guidance covers the following: 1. iso: / damd 1 medical devices symbols to be used with information to be supplied by the manufacturer part 1: general requirements amendment 1: addition of defined term for authorized representative and modified ec rep symbol to not be country or region specific. 1 authorized representative in the european community/ european union. contains biological material of human origin 6. part 1: general requirements dispositifs médicaux — symboles à utiliser avec les étiquettes, l' iso 15223 1 pdf étiquetage et les informations à fournir relatifs aux dispositifs médicaux — partie 1: exigences générales ics: 01. cd/ dvd- rom, usb stick, website). iso: medical devices - symbols to be used with information to be supplied by the manufacturer - part 1: general requirements. a list of all parts in the iso 15223 series can be found on the iso website. iso: / iso: – medical device - symbols to be used with information to be supplied by the manufacturer - part 1: general requirements symbol symbol title symbol description standard reference manufacturer indicates the medical device manufacturer 15223 5. contains human blood or plasma derivatives 3. 1 this corrected version of iso: incorporates the following correction: — in a. the main changes compared to the previous edition are as follows: — addition of 20 symbols that were validated as per iso; — addition of 5 symbols previously published in iso 7000, iso 7001 and iec 60417;. 4 caution indicates that the instructions for use contain important cautionary information such. iso: medical devices. note future symbols intended to appear in this document are to be validated in accordance with iso5223- 2. iso: ( e) pdf disclaimer this pdf file may contain embedded typefaces. 01 reference number iso/ dis: ( e) draft international standard iso/ disiso/ tc 210.