C00 标准化、质量管理 标准查询与下载



共找到 200 条与 标准化、质量管理 相关的标准,共 14

Green standards of medicinal plants and preparations for foreign trade and economy

ICS
11
CCS
C00
发布
2005-02-16
实施
2005-04-01

Capacitors for Use in Tubular Fluorescent and Other Discharge Lamp Circuits General and Safety Requirements IEC 1048

Health Informatics Integration of a Reference Terminology Model for Nursing in the First Edition

ICS
CCS
C00
发布
2005-02-01
实施

General Instructions for CSA Standards are now called Updates. Please contact CSA Information Products Sales or visit www.ShopCSA.ca for information about the CSA Standards Update Service.

The essential principles of the ISO 15189:2003 standard A practical guide for the implementation of the ISO 15189:2003 standard in medical biology analysis laboratories

ICS
CCS
C00
发布
2005
实施

CSA Standard W47.2-M1987, Certification of Companies for Fusion Welding of Aluminum, consists of 73 pages, each dated January 1987. in the form of replacement pages may be issued from time to time; such pages will be mailed automatically to those purch

The ISO 15189:2003 essentials A practical handbook for implementing the ISO 15189:2003 Standard for medical laboratories First Edition

ICS
CCS
C00
发布
2004-07-01
实施

L’entrepreneur doit fournir un négatoscope d’une puissance suffisante pour permettre la lecture sans difficulté de radiogrammes d’une densité de 3,5. L’utilisation d’un négatoscope à intensité lumineuse variable est recommandée.

The ISO 14971:2000 Essentials 1st edition A practical handbook for implementing the ISO 14971 Standards for medical devices First Edition

ICS
CCS
C00
发布
2003-07
实施

The objective of this Standard is to establish minimum criteria for effective emergency preparedness and response.

Swimming Equipment and Site.Third Edition

ICS
CCS
C00
发布
2003-06-01
实施

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.

Medical devices - Quality management systems - Requirements for regulatory purposes

ICS
11.040.01
CCS
C00
发布
2003
实施

Medical devices Quality management systems Requirements for regulatory purposes Second Edition; ISO 13485: 1996

Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition

ICS
CCS
C00
发布
2003
实施

This Guideline has been developed as a complementary document to CSA Standard Z195-02, Protective Footwear. It is intended to provide advice to protective footwear users and regulatory authorities. While this Guideline is intended to be used separately

Eye and Face Protectors Sixth Edition: Update 1

ICS
CCS
C00
发布
2002-11
实施

The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 191 9 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonsta

Lunettes De Protection: Guide De L碪tilisateur

ICS
CCS
C00
发布
2002-09-01
实施

本规则适用于空心纤维透析器,该产品是配合血液透析装置供急慢性肾功能衰竭等患者进行血液透析用的医疗器械。

Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于人工心肺机 滚压式搏动血泵,该产品是供医疗单位施行心脏直视手术时,代替人体心脏功能进行体外循环的医疗器械。

Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Roller Type Blood Pump

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于滚压式搏动血泵,该产品是供医疗单位施行心脏直视手术时,代替人体心脏功能进行体外循环使用的医疗器械。

Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Rolling Type Pulsating Blood Pump

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用的产品范围为:在中华人民共和国境内使用的各类消防产品。

Implementation Rules for Compulsory Certification of Fire Protection Products Sprinkler System Products

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用的植入式心脏起搏器产品是指所有完全植入式心脏起搏器,但不覆盖同位素电池的起搏器(核能起搏器)。

Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用的心电图机是指提供可取下供诊断用的心电图图谱的心电图机,包括心电向量图机和负荷测试仪。

Implementation Rules for Compulsory Certification of Medical Device Products ECG Machine

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于血液透析装置,是供急慢性肾功能衰竭等患者作血液透析治疗时使用的医疗器械。

Implementation Rules for Compulsory Certification of Medical Device Products Hemodialysis Devices

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于血液净化装置的体外循环管道,该产品是供血液净化时作为血液通道使用的管道。

Implementation Rules for Compulsory Certification of Medical Device Products Extracorporeal Circulation Pipeline of Blood Purification Devices

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于人工心肺机 鼓泡式氧合器,该产品是用于体外循环施行心脏直视手术时,代替人体肺功能进行气体交换的医疗器械。

Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Bubble Oxygenator

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01

本规则适用于人工心肺机 热交换器,该产品是指体外循环时调节血温的医疗器械。

Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Heat Exchanger

ICS
CCS
C00
发布
2001-12-07
实施
2002-05-01



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