Medicinsk utrustning

Kommittébeteckning: SIS/TK 355 (Medicintekniska kvalitetssystem)
Källa: CEN
Svarsdatum: den 2 jun 2019
Se merSe mindre
 

This document specifies the requirements for information supplied by the manufacturer for a medical device or accessory, as defined in 3.1. This document includes the generally applicable requirements for identification, marking and documentation of a medical device or accessory. This document does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.

This document has been prepared to support:

 the essential principles of safety and performance for the information supplied by the manufacturer of a  medical device according to ISO 16142-1:2016 (see Annex C); and

 the essential principles of safety and performance for the information supplied by the manufacturer of an IVD medical device according to ISO 16142-2:2017 (see Annex C);

 IMDRF/GRRP WG/N47:2018 [3] (see Annex D); 

 IMDRF/GRRP WG/N52:— [4] (see Annex D).

NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and documentation of a medical device or accessory.

The requirements of a medical device-specific product standard take priority over this document.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 13 jun 2019
Se merSe mindre
 

This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers.

This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards: — addition of a definition on interchangeable anaesthetic vapour delivery system; — marking the mass of mobile me equipment; — movement over a threshold; — rough handling test; — multiple socket-outlets; — specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use; — vapour concentration during and after oxygen flush; — inspiratory pause. Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

This document specifies requirements for so-called "cold bubble-through" or "cold pass-over" humidifying equipment, hereafter referred to as a passive humidifier. Figure 1 and Figure 2 illustrate these passive humidifiers.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

ISO 27427:2013 specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. ISO 27427:2013 includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life. ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD). NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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 IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[4]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84 [5] [1], the future replacement for ISO 10651‑3[6]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[7]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[8]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 jun 2019
Se merSe mindre
 

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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 IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[5]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[6][1], the future replacement for ISO 10651‑3[7]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[8]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[9]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 21 jul 2019
Se merSe mindre
 

Part 2 of ISO 25539 specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

NOTE Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this standard, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.

Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this standard, but test methods are not described for the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this standard. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539 (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters — Sterile and single-use catheters, specific to the use of balloons with vascular stents.

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow diverters are within the scope of this standard, but comprehensive requirements and testing are not described for these devices.

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive with respect to the drug-eluting properties of these devices.

NOTE Vascular device-drug combination products are within the scope of ISO 12417-1 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products.

Although absorbable stents and stents with absorbable coatings are within the scope of this standard, this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE Absorbable implants are within the scope of ISO/TS 17137 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.

Although coated stents and coated stent systems are within the scope of this standard, this standard is not comprehensive with respect to coatings.

NOTE Some coating properties are within the scope of ISO 17327-1 Non-active surgical implants — Implant coating — Part 1: General requirements.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.

 

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 27 jul 2019
Se merSe mindre
 

This part of ISO 10555 specifies requirements, performance, and user safety issues related to

subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition

and intended for single use.

This part of ISO 10555 does not specify requirements, performance, and user safety issues related to

non-coring needles.

NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as

intra-peritoneal, intra-thecal, intra-pleural, and epidural access.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
Se merSe mindre
 

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.

This document does not apply to syringes for use with insulin (specified in ISO 8537[2]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
Se merSe mindre
 

This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon commencement of injection of a nominal fixed dose of vaccine, the auto-disable feature of the syringe is passively activated so that the syringe cannot be reused.

This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes (specified in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

NOTE Prefilled syringes are covered under ISO 11040- series.