Products covered: Quality management and quality assurance (ICS 03.120.10), Laboratory medicine in general (ICS 11.100.01) This addendum concerns the notification of the Ministerial Decree No.1094/2019 (1 page, in Arabic) that gives the producers and importers twelve-month transitional period to abide by the Egyptian Standard ES 8281 "Medical analysis laboratories – minimum requirements for design, administrative and technical requirements for construction and operation" (19 pages, in Arabic). It should be noted that the draft of this Egyptian standard was formerly notified in G/TBT/N/EGY/220 dated 17 September 2019. Worth mentioning is that this standard complies with: ISO 15189:2012. Laboratory quality management system: handbook - 1. Laboratories — organization and administration, 2. Laboratories — handbooks, 3. Laboratories techniques and procedures — standards, 4.Quality control, 5.Manual - WHO document No. (ISBN 978 92 4 154827 4) Version 1.1. Producers and importers are kept informed of any amendments in the Egyptian standard through the publication of administrative orders in the official gazette. Proposed date of adoption: 29/11/2019 Proposed date of entry into force: 17/12/2019 Agency or authority designated to handle comments and text available from:National Enquiry PointEgyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: eos@idsc.net.eg/eos.tbt@eos.org.egWebsite: http://www.eos.org.egTel: + (202) 22845528Fax: + (202) 22845504

当前位置：首页 / TBT/SPS通报 /Products covered: Quality management and quality assurance (ICS 03.120.10), Laboratory medicine in general (ICS 11.100.01) This addendum concerns the notification of the Ministerial Decree No.1094/2019 (1 page, in Arabic) that gives the producers and importers twelve-month transitional period to abide by the Egyptian Standard ES 8281 "Medical analysis laboratories – minimum requirements for design, administrative and technical requirements for construction and operation" (19 pages, in Arabic). It should be noted that the draft of this Egyptian standard was formerly notified in G/TBT/N/EGY/220 dated 17 September 2019. Worth mentioning is that this standard complies with: ISO 15189:2012. Laboratory quality management system: handbook - 1. Laboratories — organization and administration, 2. Laboratories — handbooks, 3. Laboratories techniques and procedures — standards, 4.Quality control, 5.Manual - WHO document No. (ISBN 978 92 4 154827 4) Version 1.1. Producers and importers are kept informed of any amendments in the Egyptian standard through the publication of administrative orders in the official gazette. Proposed date of adoption: 29/11/2019 Proposed date of entry into force: 17/12/2019 Agency or authority designated to handle comments and text available from:National Enquiry PointEgyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: eos@idsc.net.eg/eos.tbt@eos.org.egWebsite: http://www.eos.org.egTel: + (202) 22845528Fax: + (202) 22845504

Products covered: Quality management and quality assurance (ICS 03.120.10), Laboratory medicine in general (ICS 11.100.01) This addendum concerns the notification of the Ministerial Decree No.1094/2019 (1 page, in Arabic) that gives the producers and importers twelve-month transitional period to abide by the Egyptian Standard ES 8281 "Medical analysis laboratories – minimum requirements for design, administrative and technical requirements for construction and operation" (19 pages, in Arabic). It should be noted that the draft of this Egyptian standard was formerly notified in G/TBT/N/EGY/220 dated 17 September 2019. Worth mentioning is that this standard complies with: ISO 15189:2012. Laboratory quality management system: handbook - 1. Laboratories — organization and administration, 2. Laboratories — handbooks, 3. Laboratories techniques and procedures — standards, 4.Quality control, 5.Manual - WHO document No. (ISBN 978 92 4 154827 4) Version 1.1. Producers and importers are kept informed of any amendments in the Egyptian standard through the publication of administrative orders in the official gazette. Proposed date of adoption: 29/11/2019 Proposed date of entry into force: 17/12/2019 Agency or authority designated to handle comments and text available from:National Enquiry PointEgyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: eos@idsc.net.eg/eos.tbt@eos.org.egWebsite: http://www.eos.org.egTel: + (202) 22845528Fax: + (202) 22845504

来源：epingalert 发布时间：2020-01-08 浏览量：*

通告成员：

Egypt

通告类型：

TBT

通告发布时间：

2020-01-08

评议截止时间：

通告描述：

文档编号：

G/TBT/N/EGY/220/Add.1

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原文文档翻译文档

ICS Code：

03.120.10 - Quality management and quality assurance;03.120.10 - Quality management and quality assurance;11.100.01 - Laboratory medicine in general

通告目的：

Protection of human health or safety (TBT)

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