For all of you in the medical device field, the BS EN 980 (Official English language edition of EN-980) “Symbols for use in the labelling of medical devices” has been a must-have in your conformance documentation collection. Now the European standard has been withdrawn and replaced by the new 2012 issue of BS EN ISO 15223-1, “Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements.” Available at Document Center Inc., the new integrated standard provides consolidated International and European requirements for symbols used in medical device labelling.
The text of ISO 15223-1:2012 was approved by CEN as a EN ISO 15223-1:2012 without any modification. Use of the standard is a means of conforming to the New Approach Directive 93/42/EEC on medical devices.
In addition to the text of ISO 15223-1, the EN adoption BS EN ISO 15223-1:2012 contains three informative Annexes. The first is Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical device.” The second is Annex ZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices.” And the third is Annex ZC, “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices.”
Expect to see more adoptions of the ISO 15223-1:2012 across various jurisdictions during the next few months.
All these documents plus a wide variety of other standards used by the Medical Device Industry are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone at +650-591-7600, fax at +650-591-7617 or by email at email@example.com. You may also want to review our other audit and monitoring services for standards that are particularly helpful to organizations who are required to pass conformance audits on a regular basis.
Tags: BS EN 980, BS EN 980:2008, BS EN ISO 15223-1, BS EN ISO 15223-1:2012, EN 980, EN 980:2008, EN ISO 15223-1, EN ISO 15223-1:2012, ISO 15223-1, ISO 15223-1:2012, Medical Devices. Symbols To Be Used With Medical Device Labels Labeling And Information To Be Supplied. General Requirements, Symbols for use in the labelling of medical devices