MINOR REVISION

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      30 pages
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      1 day

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

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      76 pages
      English language
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This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnos...
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    • Technical specification
      38 pages
      English language
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    • Technical specification
      37 pages
      English language
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This document presents guidelines for the design and development of cognitively accessible systems, including products and services and built environments.
This document is relevant to mainstream systems as well as those designed specifically for people with disability.
Within the broad field of accessibility, this document is limited to guidance related to cognitive accessibility.
NOTE 1 It acknowledges, however, that diverse sensory perceptions can impact cognitive accessibility.
NOTE 2 Wh...
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      31 pages
      English language
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      28 pages
      English language
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This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical system...
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    • Standard
      149 pages
      English language
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      146 pages
      English language
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    • Standard
      2 pages
      English language
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    • Standard
      2 pages
      French language
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    • Draft
      13 pages
      English language

This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.

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    • Standard
      18 pages
      English language
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    • Standard
      18 pages
      French language
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    • Draft
      17 pages
      English language
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    • Draft
      17 pages
      French language
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    • Standard
      1 page
      English language
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      1 page
      English language

This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.

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      4 pages
      English language
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      4 pages
      English language
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    • Standard
      41 pages
      English language
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This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intend...view more

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      15 pages
      English language
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    • Standard
      17 pages
      French language
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      15 pages
      English language
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    • Draft
      17 pages
      French language

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at press...view more

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    • Standard
      47 pages
      English language
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    • Standard
      51 pages
      French language
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    • Draft
      47 pages
      English language

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pr...
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    • Standard
      47 pages
      English language

This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures, such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

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    • Standard
      5 pages
      English language
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      5 pages
      English language

This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.

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    • Standard
      24 pages
      English language
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      1 day
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    • Standard
      18 pages
      English language
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    • Standard
      19 pages
      French language
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      18 pages
      English language
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      19 pages
      French language

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

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    • Amendment
      10 pages
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This document specifies dimensions and performance requirements for excavators used in dentistry.

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    • Standard
      11 pages
      English language
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    • Standard
      12 pages
      French language
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      11 pages
      English language
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    • Draft
      12 pages
      French language

This document specifies requirements for check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.
NOTE   The functional requirements in this document also apply to built-in check valves.

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      18 pages
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (...view more

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    • Standard
      25 pages
      English language
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    • Standard
      27 pages
      French language
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      36 pages
      English language

NOTEÂ 1Â Â Â Â Â Â Â There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not speci...view more

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    • Standard
      72 pages
      English language
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    • Standard
      74 pages
      French language
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      72 pages
      English language

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical ca...
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      136 pages
      English language

This document provides lists of reference standards which contain general information, implant device or application-specific information, material specifications, or test methods related to coatings. These reference standards can be used to develop product coatings for specified applications when using ISO 17327-1 to address general coating requirements. This document is applicable to coatings on non-active surgical implants.

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    • Technical report
      12 pages
      English language
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      12 pages
      English language

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as MEÂ equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTEÂ 1Â Â Â For the purposes of this document, such an environment is referred to as a critical...view more

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    • Standard
      136 pages
      English language
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    • Standard
      144 pages
      French language
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    • Draft
      136 pages
      English language
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    • Draft
      144 pages
      French language
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    • Standard
      32 pages
      English language
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      32 pages
      English language

This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) den...view more

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    • Standard
      18 pages
      English language
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    • Standard
      18 pages
      French language
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      18 pages
      English language
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    • Draft
      18 pages
      French language

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used ou...view more

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    • Standard
      107 pages
      English language
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    • Standard
      108 pages
      English language
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    • Standard
      128 pages
      French language
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    • Standard
      126 pages
      French language

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used ou...view more

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    • Standard
      107 pages
      English language

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

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    • Technical specification
      13 pages
      English language
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      13 pages
      English language

This document specifies the classification of and requirements for dental casting and dental baseplate
waxes together with the test methods to be employed to determine compliance with these requirements.
This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based
procedures.

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      28 pages
      English language
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This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does no...view more

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    • Standard
      14 pages
      English language
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    • Standard
      16 pages
      French language
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      14 pages
      English language
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    • Draft
      16 pages
      French language

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).

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    • Technical specification
      12 pages
      English language
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      12 pages
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    • Standard
      1 page
      English language
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      1 page
      English language

IEC 61828:2020 - provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound; - relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers; - gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers; - specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers. I...view more

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    • Standard
      115 pages
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This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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    • Standard
      33 pages
      English language
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    • Standard
      35 pages
      French language
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      33 pages
      English language

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document s...view more

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      24 pages
      English language
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    • Standard
      26 pages
      French language
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      24 pages
      English language

This document is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for
examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and
to the accessory devices, packaging, and labelling required for their implantation and for determining
the appropriate size of t...
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      60 pages
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This document is applicable to heart valve substitutes intended for implantation and provides general
requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the
accessory devices, packaging, and labelling required for their implantation and for determining the
appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/val...
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      87 pages
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This document provides a test method for determining the sum of residual monomeric sodium acrylate and acrylic acid present in polyacrylate superabsorbent powders as acrylic acid.

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      10 pages
      English language
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      10 pages
      English language

IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV.
This document describes the test methods employing digital detectors for determining:
a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0;
b) LINE SPREAD FUNCTIONS;
c) one-dimensional MODULATION TRANSFER FUNCTIONS;
d) FOCAL SPOT PINHOLE RADIOGRAMS,
and the means for indicating compliance.
In info...
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      47 pages
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This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by pharma producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations.

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    • Technical report
      39 pages
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    • Technical report
      39 pages
      English language
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This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. The functional requirements in this document also apply to inline check valves.

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    • Standard
      11 pages
      English language
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    • Standard
      12 pages
      French language
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      11 pages
      English language

This document applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical
diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV,
this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
NOTE 1 The FILTERING MATERIAL in the X-RAY BEAM can be removable or irremovable; it can be positioned in any
orientation or can have any shape (e.g. tapering thickness) – although usually plane-parallel material, perpendicul...
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      22 pages
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This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements. This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.

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    • Standard
      19 pages
      English language
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    • Standard
      19 pages
      French language
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    • Draft
      19 pages
      English language