ГОСТ РИСО 15378—2014
Библиография
[1]ISO 9001:2008 Quality management systems — Requirements
[2]ISO 9004 Managing for the sustained success of an organization— A quality management approach
[3]ISO 10007 Quality management systems — Guidelines tor configuration management
[4] ISO 10012 Measurement management systems — Requirements for measurement processes and measuring
equipment
[5] ISO 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices1’
16) ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
(7)ISO 11137-2 Sterrfization of health care products — Radiation — Part 2. Estabhsheig the sterilization dose
(8)ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes
(9)ISO 14001:2004 Environmental management systems — Requirements with guidance for use
(10)ISO 14644-4 Cleanrooms and associated controlled environments — Part4: Design, construction and start-up
[11JISO 14644-7 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air
hoods, gloveboxes. Isolators and mini-environments)
(12) ISO 14644-8 Cleanrooms and associated controlled environments — Part 8: Classification of airborne molecu
lar contamination
(13) ISO 14698-1 Cleanrooms and associated controlled environments — Biocontamination control — Part 1:
General principles and methods
(14) ISO 14698-2 Cleanrooms and associated controlled environments — Biocontamination control — Part 2:
Evaluation and Interpretation of biocontammation data
(15) ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a
sterilizing agentand the development, validation and routinecontrolofa sterilization process for medical devices
(16)ISO 14971:2007 Medical devices — Application of risk management to medical devices
(17)ISO 19011 Guidelines for quality andVor environmental management systems auditing
(18) ISO/IEC 90003:2004 Software engineering — Guidelines for the application of ISO 9001:2000 to computer
software
(19)ISO/IEC Guide 2 Standardization and related activities — General vocabulary
(20)ISO/IEC Guide 51:1999 Safety aspects — Guidelines for their Inclusion in standards
(21) IEC 60601-1-4 Medical electrical equipment — Part 1-4: General requirements for safety — Collateral
Standard: Programmable electrical medical systems
(22)IEC 60812 Analysis techniquesfor system reliability — Procedure forfailure mode and effects analysis (FMEA)
(23)IEC 61025 Fault tree analysis (FTA)
(24)IEC 61882 Hazard and operabifcty studies (HAZOP studies) — Application guide
(25) International vocabulary of basic and general terms in metrology (VIM). BIPM. IEC. IFCC. ISO. IUPAC. IUPAP.
OIML, 1993
(26) EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
http://ec.europa.eu/health/documents
(27)US/FDA Code of Federal Regulations
(28)GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems,
http://www.lspe.org
(29) PIC/S Guide PE 008-3. Explanatory Notes for Industry on the Preparation of a Site Master File.
http://www.picscheme.org/plcs.php
(30)ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,
http://www.ich.org
(31) EU Guidelines to Good Manufacturing Practice for Medical Products for Human and Veterinary Use, Annex 18
GoodManufactunngPracticeforActivePharmaceuticalIngredientsRequirements.
http://ec.europa.eu/health/documents/
(32) Global Harmonization Task Force (GHTF)— Study Group 1 (SGI). Document No. N029R15. 2005.
http://ghtf.org/
1> Under preparation.
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