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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

Pages: 146

Publication date: 2019-08-30

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AAMI GMP1.5

GMP Manual 5th edition - Complying with FDA Good Manufacturing Practice requirements: How to develop your Quality Systems Manual

Pages: 412

Publication date: 1997-02-01

View detail

AAMI CE-293

The CE Mark: Understanding the Medical Device Directive

Pages: 112

Publication date: 1997-01-01

View detail

AAMI Category

Anesthetic and Respiratory Equipment

Biological Evaluation

Biomedical Equipment

Biomedical Equipment in General

General Surgery / General Hospital Use

Neurosurgery / Neurology

Dialysis Equipment

Electromedical Equipment

Diagnostic and Monitoring

Electromedical Equipment in General

General Surgery / General Hospital Use

Maintenance, Design, and Electrical Safety

Miscellaneous

Therapy and Surgery; Cardiovascular

Miscellaneous

GMP/Quality Systems

General Aspects of Medical Devices

Human Factors

Implants and Artificial Organs

Implants and Artificial Organs in General

Other than Dialysis

Monographs

Reuse

Sterilization Standards

EO and Chemical Disinfection

General and Miscellaneous

Radiation

Sterilization Standards in General

Thermal

Symbols

Technology Management

General and Miscellaneous

ICS Code

(01) Generalities. Terminology. Standardization. Documentation

01.040.27 - Energy and heat transfer engineering (Vocabularies)

01.060 - Quantities and units

01.070 - Colour coding

01.075 - Character symbols

01.080 - Graphical symbols

01.100 - Technical drawings

01.020 - Terminology (principles and coordination), Including terminography

01.040 - Vocabularies

01.110 - Technical product documentation

01.120 - Standardization. General rules

01.140 - Information sciences. Publishing

(03) Services. Company organiza, management and quality. Administration. Transprort. Sociology

03.020 - Sociology. Demography

03.040 - Labour. Employment

03.060 - Finances. Banking. Monetary systems. Insurance

03.080 - Services

03.100 - Company organization and management

03.120 - Quality

03.140 - Patents. Intellectual property

03.160 - Law. Administration

03.180 - Education

03.200 - Leisure. Tourism

03.220 - Transport

03.240 - Postal services

(07) Mathematics. Natural sciences

07.020 - Mathematics

07.030 - Physics. Chemistry

07.040 - Astronomy. Geodesy. Geography

07.060 - Geology. Meteorology. Hydrology

07.080 - Biology. Botany. Zoology

07.100 - Microbiology

(11) Health care technology

11.020 - Medical sciences and health care facilities in general

11.040 - Medical equipment

11.060 - Dentistry

11.080 - Sterilization and disinfection

11.100 - Laboratory medicine

11.120 - Pharmaceutics

11.140 - Hospital equipment

11.160 - First aid

11.180 - Aids for disabled or handicapped persons

11.200 - Birth control. Mechanical contraceptives

11.220 - Veterinary medicine

(13) Environment. Health protection. Safety

13.020 - Environmental protection

13.030 - Wastes

13.040 - Air quality

13.060 - Water quality

13.080 - Soil quality. Pedology

13.100 - Occupational safety. Industrial hygiene

13.110 - Safety of machinery

13.120 - Domestic safety

13.140 - Noise with respect to human beings

13.160 - Vibration and shock with respect to human beings

13.180 - Ergonomics

13.200 - Accident and disaster control

13.220 - Protection against fire

13.230 - Explosion protection

13.240 - Protection against excessive pressure

13.260 - Protection against electric shock. Live working

13.280 - Radiation protection

13.300 - Protection against dangerous goods

13.310 - Protection against crime

13.320 - Alarm and warning systems

13.340 - Protective equipment

(17) Metrology and measurement. Physical phenomena

17.160 - Vibrations, shock and vibration measurements

17.180 - Optics and optical measurements

17.200 - Thermodynamics and temperature measurements

17.220 - Electricity. Magnetism. Electrical and magnetic measurements

17.240 - Radiation measurements

17.020 - Metrology and measurement in general

17.040 - Linear and angular measurements

17.060 - Measurement of volume, mass, density, viscosity

17.080 - Measurement of time, velocity, acceleration, angular velocity

17.100 - Measurement of force, weight and pressure

17.120 - Measurement of fluid flow

17.140 - Acoustics and acoustic measurements

(19) Testing

19.020 - Test conditions and procedures in general

19.040 - Environmental testing

19.060 - Mechanical testing

19.080 - Electrical and electronic testing

19.100 - Non-destructive testing

19.120 - Particle size analysis. Sieving

(21) Mechanical systems and components for general use

21.020 - Characteristics and design of machines, apparatus, equipment

21.040 - Screw threads

21.060 - Fasteners

21.080 - Hinges, eyelets and other articulated joints

21.100 - Bearings

21.120 - Shafts and couplings

21.140 - Seals, glands

21.160 - Springs

21.180 - Housings, enclosures, other machine parts

21.200 - Gears

21.220 - Flexible drives and transmissions

21.240 - Rotary-reciprocating mechanisms and their parts

21.260 - Lubrication systems

(23) Fluid systems and components for general use

23.020 - Fluid storage devices

23.040 - Pipeline components and pipelines

23.060 - Valves

23.080 - Pumps

23.120 - Ventilators. Fans. Air-conditioners

23.140 - Compressors and pneumatic machines

23.160 - Vacuum technology

(25) Manufacturing engineering

25.020 - Manufacturing forming processes

25.040 - Industrial automation systems

25.060 - Machine tool systems

25.080 - Machine tools

25.100 - Cutting tools

25.120 - Chipless working equipment

25.140 - Hand-held tools

25.160 - Welding, brazing and soldering

25.180 - Industrial furnaces

25.200 - Heat treatment

25.220 - Surface treatment and coating

25.240 -

(27) Energy and heat transfer engineering

27.010 - Energy and heat transfer engineering in general

27.020 - Internal combustion engines

27.040 - Gas and steam turbines. Steam engines

27.060 - Burners. Boilers

27.070 - Fuel cells

27.075 - Hydrogen technologies (Industrial application of gases, see 71.100.20)

27.080 - Heat pumps

27.100 - Power stations in general

27.120 - Nuclear energy engineering

27.140 - Hydraulic energy engineering

27.160 - Solar energy engineering

27.180 - Wind turbine energy systems

27.190 - Biological sources and alternative sources of energy

27.200 - Refrigerating technology

27.220 - Heat recovery. Thermal insulation

(29) Electrical engineering

29.160 - Rotating machinery

29.180 - Transformers. Reactors

29.200 - Rectifiers. Converters. Stabilized power supply

29.220 - Galvanic cells and batteries

29.240 - Power transmission and distribution networks

29.260 - Electrical equipment for working in special conditions

29.280 - Electric traction equipment

29.300 -

29.020 - Electrical engineering in general

29.030 - Magnetic materials

29.035 - Insulating materials

29.040 - Insulating fluids

29.045 - Semiconducting materials

29.050 - Superconductivity and conducting materials

29.060 - Electrical wires and cables

29.080 - Insulation

29.100 - Components for electrical equipment

29.120 - Electrical accessories

29.130 - Switchgear and controlgear

29.140 - Lamps and related equipment

(31) Electronics

31.020 - Electronic components in general

31.040 - Resistors

31.060 - Capacitors

31.080 - Semiconductor devices

31.100 - Electronic tubes

31.120 - Electronic display devices

31.140 - Piezoelectric devices

31.160 - Electric filters

31.180 - Printed circuits and boards

31.190 - Electronic component assemblies

31.200 - Integrated circuits. Microelectronics

31.220 - Electromechanical components for electronic and telecommunications equipment

31.240 - Mechanical structures for electronic equipment

31.260 - Optoelectronics. Laser equipment

(33) Telecommunications. Audio and video engineering

33.020 - Telecommunications in general

33.030 - Telecommunication services. Applications

33.040 - Telecommunication systems

33.050 - Telecommunication terminal equipment

33.060 - Radiocommunications

33.070 - Mobile services

33.080 - Integrated Services Digital Network (ISDN)

33.100 - Electromagnetic compatibility (EMC)

33.120 - Components and accessories for telecommunications equipment

33.140 - Special measuring equipment for use in telecommunications

33.160 - Audio, video and audiovisual engineering

33.170 - Television and radio broadcasting

33.180 - Fibre optic communications

33.200 - Telecontrol. Telemetering

(35) Information technology. Office machines

35.020 - Information technology (IT) in general

35.040 - Character sets and information coding

35.060 - Languages used in information technology

35.080 - Software

35.100 - Open systems interconnection (OSI)

35.110 - Networking

35.120 - Mang luoi dich vu to hop don le

35.140 - Computer graphics

35.160 - Microprocessor systems

35.180 - IT terminal and other peripheral equipment

35.200 - Interface and interconnection equipment

35.220 - Data storage devices

35.230 - Thiet bi nho quang hoc

35.240 - Applications of information technology

35.260 - Office machines

(37) Image technology

37.020 - Optical equipment

37.040 - Photography

37.060 - Cinematography

37.080 - Document imaging applications

37.100 - Graphic technology

(39) Precision mechanics. Jewellery

39.020 - Precision mechanics

39.040 - Horology

39.060 - Jewellery

(43) Road vehicles engineering

43.020 - Road vehicles in general

43.040 - Road vehicle systems

43.060 - Internal combustion engines for road vehicles

43.080 - Commercial vehicles

43.100 - Passenger cars. Caravans and light trailers

43.120 - Electric road vehicles

43.140 - Motorcycles and mopeds

43.150 - Cycles

43.160 - Special purpose vehicles

43.180 - Diagnostic, maintenance and test equipment

(45) Railway engineering

45.120 - Equipment for railway/cableway construction and maintenance

45.020 - Railway engineering in general

45.040 - Materials and components for railway engineering

45.060 - Railway rolling stock

45.080 - Rails and railway components

45.100 - Cableway equipment

(47) Shipbuilding and marine structures

47.020 - Shipbuilding and marine structures in general

47.040 - Seagoing vessels

47.060 - Inland navigation vessels

47.080 - Small craft

(49) Aircraft and space vehicle engineering

49.020 - Aircraft and space vehicles in general

49.025 - Materials for aerospace construction

49.030 - Fasteners for aerospace construction

49.035 - Components for aerospace construction

49.040 - Coatings and related processes used in aerospace industry

49.045 - Structure and structure elements

49.050 - Aerospace engines and propulsion systems

49.060 - Aerospace electric equipment and systems

49.080 - Aerospace fluid systems and components

49.090 - On-board equipment and instruments

49.095 - Passenger and cabin equipment

49.100 - Ground service and maintenance equipment

49.120 - Cargo equipment

49.140 - Space systems and operations

(53) Materials handling equipment

53.020 - Lifting equipment

53.040 - Continuous handling equipment

53.060 - Industrial trucks

53.080 - Storage equipment

53.100 - Earth-moving machinery

53.120 - Equipment for manual handling

(55) Packaging and distribution of goods

55.020 - Packaging and distribution of goods in general

55.040 - Packaging materials and accessories

55.060 - Spools. Bobbins

55.080 - Sacks. Bags

55.100 - Bottles. Pots. Jars

55.120 - Cans. Tins. Tubes

55.130 - Aerosol containers

55.140 - Barrels. Drums. Canisters

55.160 - Cases. Boxes. Crates

55.180 - Freight distribution of goods

55.200 - Packaging machinery

55.220 - Storing. Warehousing

55.230 - Distribution and vending machines

(59) Textile and leather technology

59.020 - Processes of the textile industry

59.040 - Textile auxiliary materials

59.060 - Textile fibres

59.080 - Products of the textile industry

59.100 - Materials for the reinforcement of composites

59.120 - Textile machinery

59.140 - Leather technology

(61) Clothing industry

61.020 - Clothes

61.040 - Headgear. Clothing accessories. Fastening of clothing

61.060 - Footwear

61.080 - Sewing machines and other equipment for the clothing industry

(65) Agriculture

65.020 - Farming and forestry

65.040 - Farm buildings, structures and installations

65.060 - Agricultural machines, implements and equipment

65.080 - Fertilizers

65.100 - Pesticides and other agrochemicals

65.120 - Animal feeding stuffs

65.140 - Beekeeping

65.145 - Hunting

65.150 - Fishing and fish breeding

65.160 - Tobacco, tobacco products and related equipment

(67) Food technology

67.160 - Beverages

67.180 - Sugar. Sugar products. Starch

67.190 - Chocolate

67.200 - Edible oils and fats. Oilseeds

67.220 - Spices and condiments. Food additives

67.230 - Prepackaged and prepared foods

67.240 - Sensory analysis

67.250 - Materials and articles in contact with foodstuffs

67.260 - Plants and equipment for the food industry

67.020 - Processes in the food industry

67.040 - Food products in general

67.050 - General methods of tests and analysis for food products

67.060 - Cereals, pulses and derived products

67.080 - Fruits. Vegetables

67.100 - Milk and milk products

67.120 - Meat, meat products and other animal produce

67.140 - Tea. Coffee. Cocoa

(71) Chemical technology

71.020 - Production in the chemical industry

71.040 - Analytical chemistry

71.060 - Inorganic chemicals

71.080 - Organic chemicals

71.100 - Products of the chemical industry

71.120 - Equipment for the chemical industry

(73) Mining and minerals

73.020 - Mining and quarrying

73.040 - Coals

73.060 - Metalliferous minerals and their concentrates

73.080 - Non-metalliferous minerals

73.100 - Mining equipment

73.120 - Equipment for processing of minerals

(75) Petroleum and related technologies

75.020 - Extraction and processing of petroleum and natural gas

75.040 - Crude petroleum

75.060 - Natural gas

75.080 - Petroleum products in general

75.100 - Lubricants, industrial oils and related products

75.120 - Hydraulic fluids

75.140 - Waxes, bituminous materials and other petroleum products

75.160 - Fuels

75.180 - Equipment for petroleum and natural gas industries

75.200 - Petroleum products and natural gas handling equipment

(77) Metallurgy

77.020 - Production of metals

77.040 - Testing of metals

77.060 - Corrosion of metals

77.080 - Ferrous metals

77.100 - Ferroalloys

77.120 - Non-ferrous metals

77.140 - Iron and steel products

77.150 - Products of non-ferrous metals

77.160 - Powder metallurgy

77.180 - Equipment for the metallurgical industry

(79) Wood technology

79.020 - Wood technology processes

79.040 - Wood, sawlogs and sawn timber

79.060 - Wood-based panels

79.080 - Semi-manufactures of timber

79.100 - Cork and cork products

79.120 - Woodworking equipment

(81) Glass and ceramics industries

81.020 - Processes in the glass and ceramics industries

81.040 - Glass

81.060 - Ceramics

81.080 - Refractories

81.100 - Equipment for the glass and ceramics industries

(83) Rubber and plastic industries

83.020 - Manufacturing processes in the rubber and plastics industries

83.040 - Raw materials for rubber and plastics

83.060 - Rubber

83.080 - Plastics

83.100 - Cellular materials

83.120 - Reinforced plastics

83.140 - Rubber and plastics products

83.160 - Tyres

83.180 - Adhesives

83.200 - Equipment for the rubber and plastics industries

(85) Paper technology

85.020 - Paper production processes

85.040 - Pulps

85.060 - Paper and board

85.080 - Paper products

85.100 - Equipment for the paper industry

(87) Paint and colour industries

87.020 - Paint coating processes

87.040 - Paints and varnishes

87.060 - Paint ingredients

87.080 - Inks. Printing inks

87.100 - Paint coating equipment

(91) Construction materials and building

91.080 - Structures of buildings

91.090 - External structures

91.100 - Construction materials

91.120 - Protection of and in buildings

91.140 - Installations in buildings

91.160 - Lighting

91.180 - Interior finishing

91.190 - Building accessories

91.200 - Construction technology

91.220 - Construction equipment

91.010 - Construction industry

91.020 - Physical planning. Town planning

91.040 - Buildings

91.060 - Elements of buildings

(93) Civil engineering

93.010 - Civil engineering in general

93.020 - Earthworks. Excavations. Foundation construction. Underground works

93.025 - External water conveyance systems (Including buried and above ground installations. Internal water supply systems, see 91.140.60)

93.030 - External water conveyance systems

93.040 - Bridge construction

93.060 - Tunnel construction

93.080 - Road engineering

93.100 - Construction of railways

93.110 - Construction of ropeway

93.120 - Construction of airports

93.140 - Construction of waterways, ports and dykes

93.160 - Hydraulic construction

(95) Military engineering

95.020 - Military engineering. Military affairs. Weapons

(97) Domestic and commercial equipment. Entertainment. Sports

97.01 - Test

97.030 - Domestic electrical appliances in general

97.040 - Kitchen equipment

97.060 - Laundry appliances

97.080 - Cleaning appliances

97.100 - Domestic, commercial and industrial heating appliances

97.120 - Automatic controls for household use

97.130 - Shop fittings

97.140 - Furniture

97.145 - Ladders

97.150 - Non-textile floor coverings

97.160 - Home textiles. Linen

97.170 - Body care equipment

97.180 - Miscellaneous domestic and commercial equipment

97.190 - Equipment for children

97.195 - Items of art and handicrafts

97.200 - Equipment for entertainment

97.220 - Sports equipment and facilities