Ämnesområden

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
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This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) packaging list;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
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This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use.
This document can also be applied to accessories.
This document applies to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for self-testing.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applied to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing.
This document can also be applied to accessories.
This document applies to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 16 okt 2021
Se merSe mindre
 

This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing.
This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing.
This document can also be applied to accessories.
This document does not apply to
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 17 okt 2021
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This document applies to the basic safety and essential performance of a ventilator 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;

- intended to be operated by a healthcare professional operator; and

- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

Ämnesområden: Läder och päls
Kommittébeteckning: SIS/TK 158 (Läder och skodon)
Källa: ISO
Svarsdatum: den 17 okt 2021
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This International Standard specifies a method for assessing the propensity of dyes and pigments to migrate from leather to a synthetic substrate by determining the transfer of colour from the leather to white polymeric material in contact with it.
This method is suitable for leather of all kinds at any stage of processing.

Ämnesområden: Läder och päls
Kommittébeteckning: SIS/TK 158 (Läder och skodon)
Källa: CEN
Svarsdatum: den 17 okt 2021
Se merSe mindre
 

This International Standard specifies a method for assessing the propensity of dyes and pigments to migrate from leather to a synthetic substrate by determining the transfer of colour from the leather to white polymeric material in contact with it.
This method is suitable for leather of all kinds at any stage of processing.

Kommittébeteckning: SIS/TK 111 (Vibration och stöt)
Källa: ISO
Svarsdatum: den 18 okt 2021
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This document describes the general requirements for evaluating the vibration of various coupled industrial machine types with a power above 15 kW and operating speeds between 120 min-1 and 30 000 min-1 when measurements are made in-situ. Guidelines for applying evaluation criteria are provided for measurements taken on non-rotating and rotating parts under normal operating conditions. The guidelines are presented in terms of both steady running vibration and any changes to vibration amplitude, which can occur in these steady values. The numerical values presented are intended to serve as guidelines based on worldwide machine experience, but shall be applied with due regard to specific machine features which may cause these values to be inappropriate. In general, the condition of a machine is assessed by consideration of both the shaft vibration and the associated structural vibration, as well as specific frequency components, which may not relate to the broadband severity values presented.
The machine types covered by this document include:
a) steam turbines and generators with outputs less than or equal to 40 MW (see Note 1 and Note 2);
b) steam turbines and generators with outputs greater than 40 MW which normally operate at speeds other than 1 500 min-1, 1 800 min-1, 3 000 min-1 or 3 600 min-1 (although generators seldom fall into this category) (see Note 1 and Note 2);
c) rotary compressors (see Note 2);
d) industrial gas turbines with outputs less than or equal to 3 MW (see Note 2 and Note 3);
e) turbofans (see Note 2);
f) electric motors of any type (see Note 4);
g) rolls and mills (see Note 5);
h) conveyors (see Note 5);
i) variable speed couplings;
j) blowers or fans (see Note 6).
NOTE 1 Land based steam turbines, gas turbines and generators of greater than 40 MW capacity, which run at 1500 min-1, 1800 min-1, 3000 min-1 or 3600 min-1 are covered by the requirements of ISO 20816-2; generators in hydro-electric plants are covered by ISO 20816-5;
NOTE 2 The proposed part 10 of this series of standards will be developed to cover high speed turbo-machinery. When that is completed, some machine types will be excluded from the scope of this document.
NOTE 3 Gas turbines of power greater than 3 MW are covered by ISO 20816-4
NOTE 4 When a motor is coupled to a machine covered by another part of ISO20816, the motor falls under this part if the coupling is flexible, but falls under the other standard if the coupling is rigid;

NOTE5 Machinery including a geared stage can fall under the scope of this document. However, the information relating to gearboxes - in particular, the conditions for performing acceptance tests and the influence of operating conditions (given in ISO 20816-9) - shall be taken into account when evaluating the vibration of gearboxes;
NOTE 6 The vibration criteria presented in this document are generally only applicable to fans with power ratings greater than 300 kW or fans which are not flexibly supported. As and when circumstances permit, recommendations for other types of fans, including those of lightweight sheet-metal construction, will be prepared. Until these recommendations are available, classifications can be agreed between the manufacturer and the customer, using results of previous operational experience, see also ISO 14694[4].
The following types of industrial machine are excluded from this document:
k) land-based gas turbines, steam turbines and generators with power outputs greater than 40 MW and speeds of 1 500 min-1, 1 800 min-1, 3 000 min-1 or 3 600 min-1 (see ISO 20816-2);
l) gas turbine sets with power outputs greater than 3 MW (see ISO 20816-4);
m) machine sets in hydraulic power generating and pumping plants (see ISO 20816-5);
n) reciprocating machines and machines solidly coupled to reciprocating machines (see ISO 20816-6);
o) rotodynamic pumps and any integrated or solidly coupled electric motors where the impeller is mounted directly on the motor shaft or is rigidly attached to it (see ISO 10816-7);
p) reciprocating compressor systems (See ISO 20816-8);
q) rotary positive displacement compressors (e. g. screw compressors);
r) submerged motor-pumps;
s) wind turbines (see ISO 10816-21).
The requirements of this document apply to in-situ broad-band vibration measurements taken on the shafts, bearings, bearing pedestals, or housings of machines under steady-state operating conditions within their nominal operating speed range. The requirements relate to both acceptance testing and operational monitoring. The evaluation criteria included in this document can be applied to both continuous and non-continuous monitoring situations.
The requirements of this document cover machines which may have gears or rolling element bearings, but do not address the diagnostic evaluation of the condition of those gears or bearings. (See ISO 20816-9).
The requirements in this standard are applicable only for the vibration produced by the machine set itself and not for vibration which is transmitted to the machine set from external sources.

Ämnesområden: Grafisk teknik: allmänt
Kommittébeteckning: SIS/TK 434 (Grafisk teknik)
Källa: ISO
Svarsdatum: den 18 okt 2021
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This International Standard specifies symbols for use in copy preparation and proof correction in alphabetic languages and in logographic languages. It is applicable to texts submitted for correction whatever their nature or presentation (manuscripts, typescripts, printer’s proofs, etc.) and for marking up copy for all methods of composition.
Symbols for the correction of mathematical texts and colour illustrations are not included.

Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: ISO
Svarsdatum: den 18 okt 2021
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This document defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements). It also provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.
Certification of FSMS is a third-party conformity assessment activity (as described in ISO/IEC 17000:2004, 5.5), and bodies performing this activity are third-party conformity assessment bodies.
NOTE 1 In this document, the terms “product” and “service” are used separately (in contrast with the definition of “product” given in ISO/IEC 17000).
NOTE 2 This document can be used as a criteria document for the accreditation or peer assessment of certification bodies which seek to be recognized as being competent to certify that an FSMS complies with ISO 22000. It is also intended to be used as a criteria document by regulatory authorities and industry consortia which engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of its requirements could also be useful to other parties involved in the conformity assessment of such certification bodies, and in the conformity assessment of bodies that undertake to certify the compliance of FSMS with criteria additional to, or other than, those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.
NOTE 3 Certification of an FSMS according to ISO 22000 is a management system certification, not a product certification.
Other FSMS users can use the concepts and requirements of this document provided that the requirements are adapted as necessary.

Kommittébeteckning: SIS/TK 298 (Konstruktion, tillverkning och kontroll av tryckbärande anordningar)
Källa: CEN
Svarsdatum: den 18 okt 2021
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Denna del av denna Europastandard specificerar konstruktion och beräkning av industriella metalliska rörledningssystem, inklusive stöd, som täcks av EN 13480.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: ISO
Svarsdatum: den 18 okt 2021
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This International Standard specifies a number of metadata elements that describe resources containing medical knowledge, primarily digital documents provided as web resources, accessible from databases or via file transfer, but can be applicable also to paper documents, e.g. articles in the medical literature.
The metadata elements:
— support unambiguous and international understanding of important aspects to describe a resource e.g. purpose, issuer, intended audience, legal status and scientific background;
— are applicable to different kinds of digital resources, e.g. recommendation from consensus of a professional group, regulation by a governmental authority, clinical trial protocol from a pharmaceutical company, scientific manuscript from a research group, advice to patients with a specific disease, review article;
— are possible to present to human readers including health professionals as well as citizens/patients
— are potentially usable for automatic processing e.g. to support search engines to restrict matches to documents of a certain type or quality level.
The metadata elements defined in this International Standard are not intended to:
— describe documents about a single patient, such as medical records;
— describe details of the medical content of the resource (but some idea of the content can be described via keywords or codes);
— prescribe criteria for the quality of the resource content.

Ämnesområden: Massa
Kommittébeteckning: SIS/TK 157 (Massa och papper)
Källa: CEN
Svarsdatum: den 18 okt 2021
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This document specifies the relevant International Standards to be used for the determination of physical properties of laboratory sheets made of all kind of pulps. It is applicable to laboratory sheets prepared in accordance with ISO 5269-1, ISO 5269-2 or ISO 5269-3.
In this document, it is left to the pulp producer and the pulp user to agree upon which properties are relevant to be tested. The results are, if applicable, reported in index form.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
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This document defines the stackable mounting receptacle series 3, for 2 or 4 modules used in the family of rectangular electrical modular connectors, operating temperature 175 °C continuous. The plugs corresponding to those receptacles are defined in EN 4165-002.
The protective cover corresponding to those receptacles are defined in EN 4165-018.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
Se merSe mindre
 

This document defines the plug series 2, for 2 and 4 modules used in the family of rectangular electrical connectors. The receptacles corresponding to those plugs are defined in EN 4165-002.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
Se merSe mindre
 

This document defines the plug series 2, for 2 and 4 modules used in the family of rectangular electrical connectors. The receptacles corresponding to those plugs are defined in EN 4165-002.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
Se merSe mindre
 

This document defines the rack and panel plug for 2 and 4 modules, series 2 used in the family of rectangular electrical connectors. The receptacles corresponding to those plugs are defined in EN 4165-002.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
Se merSe mindre
 

This document defines the rack and panel plug for 2 and 4 modules, series 2 used in the family of rectangular electrical connectors. The receptacles corresponding to those plugs are defined in EN 4165-002.

Kommittébeteckning: SIS/TK 619 (Obemannade Luftfartyg och UAS)
Källa: CEN
Svarsdatum: den 19 okt 2021
Se merSe mindre
 

This document defines the rack and panel rear mounted plug 2 and 4 modules, series 2 used in the family of rectangular electrical connectors. The receptacles corresponding to those plugs are defined in EN 4165-002.