Hälso- och sjukvård

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 12 apr 2020
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This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.

This document does not specify the format in which such information shall be provided.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 23 apr 2020
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ISO 8549 establishes a vocabulary of terms used in the field of external limb prosthetics and orthotics.

This document defines general terms used to describe these prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics.

The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3.

This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses.

For the purposes of this document, the abbreviated term 'prosthetics' and its derivatives only apply to external limb prosthetics; the abbreviated term 'orthotics' and its derivatives only apply to external orthotics.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 23 apr 2020
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ISO 8549 establishes a vocabulary of terms used in the fields of external limb prosthetics and orthotics.

This document defines terms used to describe external limb prostheses and the wearers of external limb prostheses.

The types of component used in the construction of prostheses are classified and described in ISO 13405–1, –2 and –3:2015.

For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics; the abbreviated term ‘orthotics’ and its derivatives only apply to external orthotics.

Alphabetical indexes of terms are provided.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 23 apr 2020
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ISO 8549 establishes a vocabulary of terms used in the field of external limb prosthetics and orthotics.

This document defines terms relating to orthoses.

This document does not include terms for orthoses which only encompass limb segments as these orthoses are limited mainly to use in the treatment of fractures and in Sports medicine. (These terms may be considered for inclusion at a future revision.)

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 24 apr 2020
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This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

Stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). However, when the prefilled syringes are provided to the user with an integrated addition, certain portions of the ISO 11608 series apply as follows:

— prefilled syringes that are provided to the user with an integrated electronic addition (e.g. electronic dose counter) are covered by relevant requirements of ISO 11608-4, but only to assess the function, feature or performance of the "addition" not the prefilled syringe;

— prefilled syringes that are provided to the user with an integrated addition that provides an automated function (e.g. an automated inserter that inserts to a predetermined insertion depth or needle safety device) are covered by relevant requirements of ISO 11608-5, but only to assess the function, feature or performance of the "addition" (as integrated into the NIS) not the prefilled syringe.

It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.

Excluded from the scope are:

— stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);

— toxicity (biocompatibility) of materials that form the medicinal product contact surfaces of the primary container closure;

— NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);

— containers that can be refilled multiple times;

— needle-free injectors;

— requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories;

— NISs intended for dental use;

— syringes and needles which are not intended for use in a NIS;

— NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).

NOTE These exclusions might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of those products.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 24 apr 2020
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This document specifies requirements, test methods and compatibility requirements for single-use, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864.

This document is not applicable to:

— needles for dental use;

— pre-filled syringe needles;

— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 24 apr 2020
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This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

— sterile hypodermic needles for single use;

— sterile hypodermic syringes for single use;

— sterile single-use syringes, with or without needle, for insulin;

— containers that can be refilled multiple times;

— containers intended for dental use;

— catheters or infusion sets that are attached or assembled separately by the user.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 24 apr 2020
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This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software.

The needle-based injection system containing electronics can be single use, reusable, and/or rechargeable. It is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).

This document applies to electronic accessories which are intended to be physically connected to a NIS or NIS-E during the NIS/NIS-E intended use.

NOTE This document includes relevant requirements derived from IEC 60601 series.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 24 apr 2020
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This document specifies requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO), including but not limited to:

a) medicinal product preparation (e.g. reconstitution);

b) needle preparation;

c) needle hiding;

d) priming;

e) dose setting;

f) needle insertion;

g) injection depth control;

h) injection of the medicinal product;

i) recording;

j) disabling the NIS-AUTO;

k) needle retraction;

l) needle shielding;

m) needle removal.

This document does not cover remote communication from the NIS-AUTO.

Automated features not included in the list above shall be specified and tested in accordance with the principles of this document.

All references to "function" in this document are by definition to be construed as automated functions (see 3.2). This document does not apply to these functions if they are performed manually by the user.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 28 apr 2020
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This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity of the data. This document is for those who commission, design and perform testing or evaluate the data to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.

This document makes recommendations and offers guidance intended to facilitate further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on  isolated tissues and organs taken from vertebrate animals that have been euthanized.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 29 apr 2020
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

— details of in vivo sensitization test procedures;

— key factors for the interpretation of the results.

NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Kommittébeteckning: SIS/TK 355 (Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik)
Källa: CEN
Svarsdatum: den 5 maj 2020
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This document identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols are marked on the medical device itself, placed on its packaging or placed in the associated accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

Kommittébeteckning: SIS/TK 599 (Kvalitetssäkring inom LSS)
Källa: SIS
Svarsdatum: den 7 maj 2020
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Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 23 maj 2020
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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 outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near  nfrared spectroscopy equipment in medical literature.

Not included within the scope of this document are:

⎯ invasive tissue or vascular oximeters;

⎯ oximeters that require a blood sample from the patient;

⎯ equipment measuring dissolved oxygen;

ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71 [2];

ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601-2-61 [2];

ME equipment, or part thereof, that claims to monitor tissue in other parts of the body other than the head.

These requirements also apply to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, which have been remanufactured.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.

NOTE 2 See also 4.2 of the general standard. “The general standard” is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.

This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.

NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 24 maj 2020
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This document specifies requirements for safety, materials, design and information to be supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. 
Tracheal tubes that include bronchus blockers are excluded from the scope of this document

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 29 maj 2020
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This International Standard specifies general requirements and test methods for assistive products intended for use to alleviate or compensate for a disability.

The aim of this International Standard is to provide safety requirements and recommendations for manufacturers of such assistive products.

This International Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.

Where other International Standards exist for particular types of assistive products then those standards apply.

NOTE 1 Assistive products may be considered to be medical devices in some jurisdictions but not in others.

NOTE 2 Not all the items listed in ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of the standard can be used for assistive products which are not medical devices.