Infoteenus
11 TERVISEHOOLDUS
Uued standardid
ISO 8637-3:2024
Extracorporeal systems for blood purification — Part 3: Plasmafilters
Käsitlusala:
This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;
— extracorporeal blood circuits;
— haemodialysers, haemodiafilters, haemofilters and haemoconcentrators;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems or equipment intended to perform plasma separation.
NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2.
NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
— extracorporeal blood circuits;
— haemodialysers, haemodiafilters, haemofilters and haemoconcentrators;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems or equipment intended to perform plasma separation.
NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2.
NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
Alusdokumendid:
Asendab:
ISO 8637-3:2018
ISO 8637-1:2024
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Käsitlusala:
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment.
NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment.
NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Alusdokumendid:
Asendab:
ISO 8637-1:2017
EVS-EN 1865-2:2024
Kiirabiautodes kasutatavad patsiendi transpordi abivahendid. Osa 2: Jõudetoega kanderaam
Käsitlusala:
This document specifies minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
Alusdokumendid:
EN 1865-2:2024
Asendab:
EVS-EN 1865-2:2010+A1:2015
ISO 11040-4:2024
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Käsitlusala:
This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
— tubing-glass barrels (single-chamber design) for injection preparations, and
— sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
— tubing-glass barrels (single-chamber design) for injection preparations, and
— sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.
Alusdokumendid:
Asendab:
ISO 11040-4:2015
ISO 9299:2024
Traditional Chinese medicine — Curcuma longa rhizome
Käsitlusala:
This document specifies the quality and safety requirements for Curcuma longa rhizome.
This document applies to the production and sale of cultivated Curcuma longa rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
This document applies to the production and sale of cultivated Curcuma longa rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
Alusdokumendid:
ISO 11040-7:2024
Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
Käsitlusala:
This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.
NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.
NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.
Alusdokumendid:
Asendab:
ISO 11040-7:2015
ISO/TS 23961-3:2024
Traditional Chinese medicine — Vocabulary for diagnostics — Part 3: Abdomen
Käsitlusala:
This document defines terms for abdominal diagnosis. The equivalent terms in Chinese characters (Pinyin), Japanese characters and Korean characters are given in Annex A.
Alusdokumendid:
Asendatud standardid
EVS-EN 1865-2:2010+A1:2015
Kiirabiautodes kasutatavad patsiendi transpordi abivahendid. Osa 2: Muudetava asendiga kanderaam
Käsitlusala:
This European Standard defines minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
Alusdokumendid:
EN 1865-2:2010+A1:2015
Asendatud:
EVS-EN 1865-2:2024
ISO 8637-1:2017
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Käsitlusala:
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.
Alusdokumendid:
Asendatud:
ISO 8637-1:2024
ISO 11040-4:2015
Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Käsitlusala:
ISO 11040-4:2015 applies to
tubing-glass barrels (single-chamber design) for injection preparations, and
sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040-4:2015.
tubing-glass barrels (single-chamber design) for injection preparations, and
sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040-4:2015.
Alusdokumendid:
Asendatud:
ISO 11040-4:2024
ISO 8637-3:2018
Extracorporeal systems for blood purification -- Part 3: Plasmafilters
Käsitlusala:
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
Alusdokumendid:
Asendatud:
ISO 8637-3:2024
ISO 11040-4:2015/Amd 1:2020
ISO 11040-4:2015 - Amendment
Käsitlusala:
Amendment to ISO 11040-4:2015
Alusdokumendid:
ISO 11040-7:2015
Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling
Käsitlusala:
ISO 11040-7:2015 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of ISO 11040-7:2015.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of ISO 11040-7:2015.
Alusdokumendid:
Asendatud:
ISO 11040-7:2024
EVS-EN 62464-2:2011
Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
Käsitlusala:
This International Standard specifies the description of PULSE SEQUENCES of MAGNETIC RESONANCE imaging. NOTE The classification in this standard is suitable for: - tender texts; - image annotation; - protocol definition; - technical publications. This International Standard does not apply to MAGNETIC RESONANCE spectroscopy. The classification does not focus on image contrast (T1, T2, proton density), as this is defined by PULSE SEQUENCE parameters (e.g. repetition time, echo time) and is not a property of the PULSE SEQUENCE alone. The PULSE SEQUENCE classification does not specify the K-SPACE acquisition scheme, reconstruction algorithm or post-processing.
Alusdokumendid:
IEC 62464-2:2010; EN 62464-2:2011
Kavandid
prEN IEC 80601-2-23:2024
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Käsitlusala:
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORS as defined in 201.3.203 hereinafter also referred to as ME EQUIPMENT or ME SYSTEM.
This document applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS intended for use in professional healthcare facilities in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This standard applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.
This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).
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 follows:
The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.
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.
NOTE See also 4.2 of the General Standard.
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORS as defined in 201.3.203 hereinafter also referred to as ME EQUIPMENT or ME SYSTEM.
This document applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS intended for use in professional healthcare facilities in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This standard applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.
This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).
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 follows:
The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.
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.
NOTE See also 4.2 of the General Standard.
Alusdokumendid:
62D/2133/CDV; prEN IEC 80601-2-23:2024
prEN 14476
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Käsitlusala:
TThis document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products, i.e, products that are not diluted when applied, - with water. Ready-to-use-products can only be tested at a concentration up to 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities, and in dental institutions;
- in clinics of schools, of kindergartens, and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test.
NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities, and in dental institutions;
- in clinics of schools, of kindergartens, and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test.
NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Alusdokumendid:
prEN 14476
prEN IEC 61675-2:2024
Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
Käsitlusala:
This part of IEC 61675 specifies terminology and test methods for describing the characteristics of GAMMA CAMERAS equipped with PARALLEL HOLE COLLIMATORS that are capable of planar imaging. Additional tests are specified for those GAMMA CAMERAS that are capable of SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) or planar wholebody imaging (PLANAR WHOLEBODY IMAGING EQUIPMENT) or SPECT wholebody imaging. SPECT systems may also be equipped with a CT system for hybrid imaging.
These GAMMA CAMERAS consist of a gantry, single or multiple DETECTOR HEADS, and a computer for data acquisition, processing, storage, and display. The DETECTOR HEADS may contain single or multiple scintillation crystals or solid state detectors.
Novel camera designs with multiple DETECTOR HEADS that are not capable of planar acquisition are not included in the scope of this standard.
These GAMMA CAMERAS consist of a gantry, single or multiple DETECTOR HEADS, and a computer for data acquisition, processing, storage, and display. The DETECTOR HEADS may contain single or multiple scintillation crystals or solid state detectors.
Novel camera designs with multiple DETECTOR HEADS that are not capable of planar acquisition are not included in the scope of this standard.
Alusdokumendid:
62C/912/CDV; prEN IEC 61675-2:2024