• :  
BM ENG
  • Home
  • Service
  • International Standard
  • FAQ
  • Publish
  • Sign In
  •  Cart ()
Search Malaysian Standard (MS)
 Advanced Search Search




Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, AMD. 1:2006, IDT)
MS ISO 10993-4:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides general requirements for evaluating the interactions of medical devices with blood. 
It describes:
a) a classification of medical and dental devices that ....Read more are intended for use in contact with blood, based on the intended use and duration of contact as defined in MS ISO 10993-1;
b) the fundamental principles governing the evaluation of the interaction of devices with blood;
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This standard describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. Close

RM 75.00

Document will be sent via email



 Add To Cart
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010, IDT)
MS ISO 10993-10:2013
Status : Original
Format : PDF

This Malaysian Standard describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This ....Read more standard includes: 
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin. Close

RM 120.00

Document will be sent via email



 Add To Cart
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000, IDT)
MS ISO 10993-15:2005 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding m ....Read more aterial samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. 
This Malaysian Standard is not applicable to degradation products induced by applied mechanical stress.

NOTE: Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of deg Close

RM 30.00

Document will be sent via email



 Add To Cart
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009, IDT)
MS ISO 10993-5:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard describes test methods to assess the in vitro cytotoxicity of medical devices. 
These methods specify the incubation of cultured cells in contact with a device and/or ex ....Read more tracts of a device either directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. Close

NOT FOR SALE

Please contact us if you are interested to purchase for reference.



BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002, IDT)
MS ISO 10993-17:2005 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies a method for the determination of allowable limits for substances leach able from medical devices. It is intended for use in deriving standards and estimating appropr ....Read more iate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. 
This Malaysian Standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).

Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This Malaysian Standard does not address the potential for exposure from such sources. Close

RM 45.00

Document will be sent via email



 Add To Cart
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001, IDT)
MS ISO 10993-14:2005 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysi ....Read more s of these solutions in order to identify the degradation products. Because of the generalized nature of this standard, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. 
This Malaysian Standard considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered.

Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified.

Although these materials are intended for biomedical applications, the biological activity of these degradation products is n Close

RM 30.00

Document will be sent via email



 Add To Cart
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)
MS ISO 10993-9:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation s ....Read more tudies. Information obtained from these studies can be used in the biological evaluation described in the MS ISO 10993 series. This standard considers both non-resorbable and resorbable materials. 
This standard is not applicable to:

a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

b) leachable components which are not degradation products;

c) medical devices or components that do not contact the patient's body directly or indirectly. Close

NOT FOR SALE

Please contact us if you are interested to purchase for reference.



Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (First revision) (ISO 10993-16:2010, IDT)
MS ISO 10993-16:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic ....Read more studies in the biological evaluation of medical devices. Close

RM 30.00

Document will be sent via email



 Add To Cart
OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES (ISO 10943:2006, IDT)
MS ISO 10943:2011
Status : Original
Format : PDF

This Malaysian Standard gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic ....Read more studies in the biological evaluation of medical devices. Close

RM 15.00

Document will be sent via email



 Add To Cart
Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006, IDT)
MS ISO 10942:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies the minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus.

RM 15.00

Document will be sent via email



 Add To Cart
  • ‹
  • 1
  • 2
  • ...
  • 184
  • 185
  • 186
  • 187
  • 188
  • 189
  • 190
  • ...
  • 581
  • 582
  • ›
©2020 All rights reserved
Department of Standards Malaysia (STANDARDS MALAYSIA). Best viewed on latest browser.