Medical devices - quality management systems - requirements for regulatory purposes (ISO 13485:2003, IDT)

Bibliographic Details
Main Author:	Department of Standards Malaysia
Format:
Language:	eng
Published:	Malaysia, MY : Department Of Standards Malaysia, 2006
Subjects:	Medical electronics

Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2016+A11:2021) /
by: British Standards Institution, owner 8096
Published: (2021)

Medical devices - quality management systems - guidance on the application of ISO 13485:2006
by: Department of Standards Malaysia
Published: (2007)

Biological evaluation of medical devices - part 1 : evaluation and testing (ISO 10993-1:2003, IDT)
by: Department of Standards Malaysia
Published: (2005)

Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 and its amendment 1:2004, IDT)
by: Department of Standards Malaysia
Published: (2005)

Medical devices - application of risk management to medical devices (first revision) (ISO 14971:2007, IDT)
by: Department of Standards Malaysia
Published: (2009)

biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003, IDT)
by: Department of Standards Malaysia
Published: (2005)

Biological evaluation of medical devices - part 13 : identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998, IDT)
by: Department of Standards Malaysia
Published: (2005)

Biological evaluation of medical devices- part 17 : establishment of allowable limits for leachable substances (ISO 10993-17:2002, IDT)
by: Department of Standards Malaysia
Published: (2005)

Biological evaluation of medical devices - part 16 : toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997, IDT)
by: Department of Standards Malaysia
Published: (2005)

Biological evaluation of medical devices - part 15 : identification and quantification of degradation of products from metals and alloys (ISO 10993-15:2000, IDT)
by: Department of Standards Malaysia
Published: (2005)

Medical electrical equipment - part 1-1: general requirements for safety - collateral standard : safety requirements for medical electrical systems (IEC 60601-1-1:2000, IDT) /
by: Malaysia. SIRIM Berhad. Department of Standards Malaysia, issuing body, et al.
Published: (2005)

Malaysian Standard : quality management systems - Requirements (second revision) (ISO 9001:2015, IDT)
by: Malaysia. SIRIM Berhad. Department of Standards Malaysia, issuing body, et al.
Published: (2015)

Medical electrical equipment - part 2-45 : particular requirements for the safety of mammographic x- ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001, IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment - part 2-50 : particular requirements for the safety of infant phototherapy equipment (IEC 60601-2-50:2005, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrical equipment - part 1 : general requirements for safety part 2. collateral standard: electromagnetic compatibility - requirements and tests (IEC 60601: 1-2 :1993, IDT)
by: Department of Standards Malaysia
Published: (2002)

Medical electrical equipment - part 2-49 : particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2006, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrical equipment - part 2-43 : particular requirements for the safety of x-ray equipment for interventional procedures (IEC 60601-2-43 : 2000, IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment - part 1-3 : general requirements for safety - collateral standard general requirements for radiation protection in diagnostic x-ray equipment (IEC 60601-1-3:1994 , IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment - part 2-7 : particular requirements for the safety of high-voltage generators of diagnostic x-ray generators (IEC 60601-2-7:1998, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrical equipment part 3-1 : essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment (IEC 60601-3-1:1996, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrical equipment part 2-11 : particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11: 1997 and its amendment 1 : 2004, IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment - part 2-51 : particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2005, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrial equipment - part 2-44 : particular requirements for the safety of x-ray equipment for computed tomography (IEC 60601-2-44 : 2001 and its amendment 1 : 2002, IDT)
by: Department of Standards Malaysia
Published: (2006)

Urine collection bags - part 2 : requirements and test methods (ISO 8669-2:1996, IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment - part 2-1 : particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV (EC 60601-2-1: 1998 and its amendment 1: 2000, IDT)
by: Department of Standards Malaysia
Published: (2006)

Medical electrical equipment part 2-8 : particular requirements for the safety of therapeutic x-ray equipment operaing in range 10 KV to 1 MV (IEC 60601-2-8:1987 and its amendment 1:1997, IDT)
by: Department of Standards Malaysia
Published: (2007)

Medical electrical equipment dosimeters with ionization chambers and/or semi-conductor detectors as used in x-ray diagnostic imaging (IEC 61674:1997 and its Amendment 1:2002, IDT)
by: Department of Standards Malaysia
Published: (2007)

Anaesthetic and respiratory equipment - tracheal tubes and connectors (ISO 5361:1999, IDT)
by: Department of Standards Malaysia
Published: (2007)

Tracheal tubes - part 4 : cole type (ISO 5361-4:1987, IDT)
by: Department of Standards Malaysia
Published: (2006)

Determination of the permanent filtration of x-ray tube assemblies (IEC 60522:2003, IDT)
by: Department of Standards Malaysia
Published: (2007)

The FDA and worldwide quality system requirements guidebook for medical devices /
by: 241799 Daniel, Amiram, et al.
Published: (2008)

Bench to Bed: Researchers’ Limited Awareness of Regulatory Requirements to Market Medical Devices
by: Tan, X. J. A., et al.
Published: (2016)

Anaesthetic and respiratory equipment - tracheostomy tubes - part 3 : paediatric tracheostomy tubes (ISO 5366 - 3:2001, IDT)
by: Department of Standards Malaysia
Published: (2005)

Regulatory affairs for biomaterials and medical devices /
by: Amato, Stephen F., et al.
Published: (2015)

Medical electrical equipment - part 1 : general requirements for basic safety and essential performance (IEC 60601-1:2005)
by: Department of Standards Malaysia
Published: (2006)

Anaesthetic and respiratory equipment - tracheostomy tubes - part 1 : tubes and connectors for use in adults (MS ISO 5366-1:2000, IDT)
by: Department of Standards Malaysia
Published: (2005)

Biological evaluation of medical devices - part 14 : identification and quantification of degradation products from ceramics
by: Malaysia. SIRIM Berhad. Department of Standards Malaysia, issuing body, et al.
Published: (2005)

Medical electrical equipment - x-ray tube assemblies for medical diagnosis - characteristics of focal spots (IEC 60336:2005, IDT)
by: Department of Standards Malaysia
Published: (2007)

Risk management assessment of a medical device based on ISO 14971 standard /
by: Siti Nurasyikin Ramlan, 1996-, author 625754, et al.
Published: (2019)

Risk management assessment of a medical device based on ISO 14971 standard /
by: Siti Nurasyikin Ramlan, 1996-, author 625754
Published: (2019)

Medical devices - quality management systems - requirements for regulatory purposes (ISO 13485:2003, IDT)

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