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MEDICAL DEVICES. BIOLOGICAL EVALUATION OF MEDICAL DEVICES.

PART 19. TESTS OF PHYSICO-CHEMICAL, MORPHOLOGICAL

AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS

 

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┌──────────────────┬────────────────────┬──────┬──────┬───────────────────┐

│- │-

( - │- │

│ ) ││

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ASTM F1854-01, [19]│

│X │- │ 18754, [22]

│ ()│- │X │ 18757, [23]

│- │X

│X │-

├──────────────────┼────────────────────┼──────┼──────┤

│- │X

│X │-

├──────────────────┼────────────────────┼──────┼──────┤

│- │X

│X │-

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ASTM F665, [35]

│X │X │ASTM F754, [38]

│ASTM F2081, [42]

│X │- │ASTM F2183, [44]

│X │X │Hasegava and

/ │X │- │Hashimoto, [55]

│X │- │Kajiyama et al.,

├──────────────────┼────────────────────┼──────┼──────┤[58]

│X │X │Kajiyama et al.,

│X │- │[59]

├──────────────────┼────────────────────┼──────┼──────┤

│X │X

│X │-

│X │-

├──────────────────┼────────────────────┼──────┼──────┤

/ │X │X

/ │X │X

│X │-

│X │-

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│EH 828, [27]

/ │Collier et al.,

│[48]

│( ) │X │X │Dewez et al., [49] │

├──────────────────┼────────────────────┼──────┼──────┤Dexter et al., [50]│

│Ebara and Okahata, │

│( ) │X │X │[53]

├──────────────────┼────────────────────┼──────┼──────┤Ikada, [56]

│X │X │Jenney and

│X │X │Anderson, [57]

│X │X │Kishida et al.,

│X │X │[60]

├──────────────────┼────────────────────┼──────┼──────┤MacDonald et al.,

│X │X │[65]

│X │X │Niikura et al.,

│ │X │X │[69]

│X │X │Qurk et al., [71]

├──────────────────┼────────────────────┼──────┼──────┤Senshu et al., [72]│

│Senshu et al., [74]│

│Sevastianov, [75]

- │X │X │Tamada et al., [77]│

│Titushkin et al.,

- │X │X │[78]

│Vasilets et al.,

- │ │X │X │[79]

│Wagner et al., [80]│

- │ │Weber et al., [82] │

- -│

├──────────────────┼────────────────────┼──────┼──────┤

- │X │X

- │X │X

- │ │X │X

- │

- -│

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ASTM D968, [31]

│ASTM D1044, [32]

│X │- │ASTM D1894, [33]

│ASTM D4060, [34]

│ASTM D732, [36]

│ , -│X │X │ASTM F735, [37]

│ASTM F1978, [41]

│X │X

│/ │X │X

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ 3274, [1]

│/ │X │X │ 4287, [2]

│- │X │- │ 4288, [3]

│/ │X │- │ 5436-1, [4]

│- │X │- │ 5436-2, [5]

│- │X │- │ 11562, [11]

│- │X │- │ 12179, [12]

│X │- │ 13565-1, [15]

│X │X │ 13565-2, [16]

├──────────────────┼────────────────────┼──────┼──────┤ 13565-3, [17]

│ 18754, [22]

- │X │- │ 18757, [23]

- │/ │X │X │ 623-4, [25]

- │X │- │Alaerts et al.,

- │X │- │[46]

│Ikada, [56]

│("", │Kajijama et al.,

│"") │[58]

│Kumaki et al., [63]│

│Senshu et al., [72]│

│Senshu et al., [73]│

│Senshu et al., [74]│

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ASTM F1877, [40]

│X │X │ 13319, [13]

│X │X │ 13320-1, [14]

│/ 13762, [18] │

│X │X │ 17853, [21]

│ () │X │- │ 725-5, [26]

│X │-

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ │ │X │X

│/ │X │X

│X │X

├──────────────────┼────────────────────┼──────┼──────┼───────────────────┤

│ 17190-5, [20]

│X │X │Moskala and Jones

│X │X │[66]

│X │X

│X │X

│X │X

│X │X

│X │X

└──────────────────┴────────────────────┴──────┴──────┴───────────────────┘

 

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8.

 

:

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c) .

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. , - , (Everitt and Bermudez, [54]). , , , , (Kreuter et al., [61]; Kreyling et al., [62]; Nemmar et al., [67]; Oberdorster et al., [70]). , , .. - (Nemmar et al., [68]). , , , , , , (Stone et al., [76]). , .

 

 

 

 

 

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10993-1

10993-1-2009. .
. 1.

10993-18

10993-18-2009. .
. 18.

 

 

 

 

 

 

[1] 3274:1996 (GPS).

. .

()

ISO 3274:1996 Geometrical Product Specifications (GPS) - Surface

texture: Profile method - Nominal characteristics

of contact (stylus) instruments

[2] 4287:1997 (GPS).

. . .

ISO 4287:1997 Geometrical Product Specifications (GPS) - Surface

texture: Profile method - Terms, definitions and

surface texture parameters

[3] 4288:1996 (GPS).

. .

ISO 4288:1996 Geometrical Product Specifications (GPS) - Surface

texture: Profile method - Rules and procedures for

the assessment of surface texture

[4] 5436-1:2000 .

: ; . 1.

ISO 5436-1:2000 Geometrical Product Specifications (GPS) - Surface

texture: Profile method; Measurement standards -

Part 1: Material measures

[5] 5436-2:2001 .

: ; . 2.

ISO 5436-2:2001 Geometrical Product Specifications (GPS) - Surface

texture: Profile method; Measurement standards -

Part 2: Software measurement standards

[6] 5832-1:1997 . .

1.

ISO 5832-1:1997 Implants for surgery - Metallic materials - Part 1:

Wrought stainless steel

[7] 10993-9:1999 .

9.

ISO 10993-9:1999 Biological evaluation of medical devices - Part 9:

Framework for identification and quantification of

potential degradation products

[8] 10993-13:1998 .

13.

ISO 10993-13:1998 Biological evaluation of medical devices - Part 13:

Identification and quantification of

degradation products from polymeric medical devices

[9] 10993-14:2001 .

14.

ISO 10993-14:2001 Biological evaluation of medical devices - Part 14:

Identification and quantification of degradation

products from ceramics

[10] 10993-15:2000 .

15.

ISO 10993-15:2000 Biological evaluation of medical devices -

Part 15: Identification and quantification of

degradation products from metals and alloys

[11] 11562:1996 (GPS).

. .

ISO 11562:1996 Geometrical Product Specifications (GPS) - Surface

texture: Profile method - Metrological

characteristics of phase correct filters

[12] 12179:2000 (GPS).

: .

()

ISO 12179:2000 Geometrical Product Specifications (GPS) - Surface

texture: Profile method - Calibration of contact

(stylus) instruments

[13] 13319:2000 .

ISO 13319:2000 Determination of particle size distributions -

Electrical sensing zone method

[14] 13320-1:1999 .

. 1.

ISO 13320-1:1999 Particle size analysis - Laser diffraction

methods - Part 1: General principles

[15] 13565-1:1996 (GPS).

: .

. 1.

ISO 13565-1:1996 Geometrical Product Specifications (GPS) - Surface

texture: Profile method; Surface having stratified

functional properties - Part 1: Filtering and

general measurement conditions

[16] 13565-2:1996 (GPS).

: .

. 2.

ISO 13565-2:1996 Geometrical Product Specifications (GPS) - Surface

texture: Profile method; Surfaces having

stratified functional properties - Part 2: Height

characterization using the linear material ratio

curve

[17] 13565-3:1998 (GPS).

: .

. 3.

ISO 13565-3:1998 Geometrical Product Specifications (GPS) - Surface

texture: Profile method; Surfaces having

stratified functional properties - Part 3: Height

characterization using the material probability

curve

[18] / 13762:2001 .

ISO/TS 13762:2001 Particle size analysis - Small angle X-ray

scattering method

[19] 14971:2000 .

ISO 14971:2000 Medical devices - Application of risk management to

medical devices

[20] 17190-5:2001 .

.

5.

ISO 17190-5:2001 Urine-absorbing aids for incontinence - Test

methods for characterizing polymer-based absorbent

materials - Part 5: Gravimetric determination of

free swell capacity in saline solution

[21] 17853:2003 .

. ,

ISO 17853:2003 Wear of implant materials - Polymer and metal wear

particles - Isolation, characterization and

quantification

[22] 18754:2003 ( ,

).

ISO 18754:2003 Fine ceramics (advanced ceramics, advanced

technical ceramics) - Determination of density

and apparent porosity

[23] 18757:2003 ( ,

).

BET

ISO 18757:2003 Fine ceramics (advanced ceramics, advanced

technical ceramics) - Determination of specific

surface area of ceramic powders by gas adsorption

using the BET method

[24] EN 455-3:1999 Medical gloves for single use - Part 3:

Requirements and testing for biological evaluation

[25] EN 623-4:2004 Advanced technical ceramics - Monolithic ceramics -

General and textural properties - Part 4:

Determination of surface roughness

[26] EN 725-5 Advanced technical ceramics - Methods of test for

ceramic powders - Part 5: Determination of the

particle size distribution

[27] EN 828:1997 Adhesives - Wettability - Determination by

measurement of contact angle and critical surface

tension of solid surface

[28] 22442-1 ,

. 1.

ISO 22442-1 Medical devices utilizing animal tissues and their

derivatives - Part 1: Application of risk

management

[29] 22442-2 ,

. 2.

,

ISO 22442-2 Medical devices utilizing animal tissues and their

derivatives - Part 2: Controls on sourcing,

collection and handling

[30] 22442-3 ,

. 3.

/

ISO 22442-3 Medical devices utilizing animal tissues and their

derivatives - Part 3: Validation of the

elimination and/or inactivation of viruses and

transmissible spongiform encephalopathy (TSE)

agents

[31] ASTM D968-05 Standard Test Methods for Abrasion Resistance of

Organic Coatings by Falling Abrasive

[32] ASTM D1044-05 Standard Test Method for Resistance of Transparent

Plastics to Surface Abrasion

[33] ASTM D1894-01 Standard Test Method for Static and Kinetic

Coefficients of Friction of Plastic Film and

Sheeting

[34] ASTM D4060-01 Standard Test Method for Abrasion Resistance of

Organic Coatings by the Taber Abraser

[35] ASTM F665-98 Standard Classification for Vinyl Chloride Plastics

Used in Biomedical Application

[36] ASTM F732-00 Standard Test Method for Wear Testing of Polymeric

Materials for Use in Total Joint Prostheses

[37] ASTM F735-94 Standard Test Method for Abrasion Resistance of

Transparent Plastics and Coatings Using the

Oscillating Sand Method

[38] ASTM F754-00 Standard Specification for Implantable

Polytetrafluoroethylene (PTFE) Polymer Fabricated

in Sheet, Tube, and Rod Shapes

[39] ASTM F1854-01 Standard Test Method for Stereological Evaluation

of Porous Coatings on Medical Implants

[40] ASTM F1877-05 Standard Practice for Characterization of Particles

[41] ASTM F1978-00 Standard Test Method for Measuring Abrasion

Resistance of Metallic Thermal Spray Coatings by

Using the TaberTM Abraser

[42] ASTM F2081-01 Standard Guide for Characterization and

Presentation of the Dimensional Attributes of

Vascular Stents

[43] ASTM F2150-02e1 Standard Guide for Characterization and Testing of

Biomaterial Scaffolds Used in Tissue-Engineered

Medical Products

[44] ASTM F2183-02 Standard Test Method for Small Punch Testing of

Ultra-High Molecular Weight Polyethylene

Used in Surgical Implants

[45] ASTM G174-04 Standard Test Method for Measuring Abrasion

Resistance of Materials by Abrasive Loop Contact

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poly(methyl methacrylate) microgrooved for contact

guidance of mammalian cells, Biomaterials, 22,

2001, pp 1635 - 1642

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intracellular calcium caused by ultrafine carbon

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Biomaterials, 19, 1998, pp 1441 - 1415

[50] DEXTER, S.J. et al. A comparison of the adhesion of

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pp 222 - 227

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