Hälso- och sjukvård

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

ISO 10322-1:2016 specifies requirements for the optical and geometrical properties of all semi-finished single-vision and multifocal spectacle lens blanks.

ISO 11979-4:2008 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator's stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging. This document applies to operating lights, irrespective of the technology of the light source. This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire. NOTE 1       Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C. NOTE 2       Respiratory therapy tubing is covered by ISO 17256. NOTE 3       Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document. The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min). NOTE 4       There is rationale for this clause in A.2. The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR). This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases. This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials. The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only. This document does not cover the step in which the user verifies a reagent (analysis method adoption). NOTE Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.

Detta dokument avser regelbunden rengöring av lokaler och inventarier inom hälso- och sjukvård för att minska smittspridning. 

Detta dokument anger: 

kriterier för olika hygien- och kvalitetsnivåer  

krav på och rekommendationer för uppföljning och kontroll av rengöring 

krav på utbildning och kompetens hos personalen samt ansvarsförhållanden  

krav på städutrustning samt 

rekommendationer för dokumenterade instruktioner om hur rengöringen utförs 

rekommendationer för städfrekvens 

Detta dokument omfattar inte rengöring som regleras i specifika lagar och föreskrifter. 

Exempel: Vissa lokalfunktioner regleras i andra dokument såsom tex Good Manufacturing Practice (GMP).  

ISO 8980-4:2006 specifies optical and non optical requirements, including durability, and test methods for anti-reflective coatings on spectacle lenses. ISO 8980-4:2006 does not deal with the following topics: transmittance and absorbtance; the colour of the reflected light.

ISO 18739:2016 specifies terms, synonyms for terms and definitions used in the process chain for CAD/CAM systems in dentistry.

The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.

ISO 11986:2017 provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses. NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses. NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.

ISO 11987:2012 specifies test procedures for determining the stability of contact lenses once placed in their final packaging during storage and distribution.

This International Standard specifies the coupling between handpieces and motors connected to dental units. This International Standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light, and rotation energy.