1.18.06.57 1f0170 draft report · 2020-05-05 · nas the masks were packaged in sealed plastic...

56 LESLIE HOUGH WAY • SALFORD • GREATER MANCHESTER • M6 6AJ • UNITED KINGDOM

Email: [email protected] Website: www.inspec-international.com

Tel: +44 (0)16 1737 0699 Fax: +44 (0)16 1736 0101

T E S T I N G A N D C E R T I F I C A T I O N O F P E R S O N A L P R O T E C T I V E E Q U I P M E N T A N D Q U A L I T Y M A N A G E M E N T S Y S T E M S

Registered Number 22183229 INSPEC International Limited Incorporated in England

Test Report

EN 149 : 2001 + A1 : 2009

Particle filtering half masks Report no: 1.18.06.57

Client: INSPEC Certification Services 56 Leslie Hough Way Salford Greater Manchester M6 6AJ United Kingdom

Manufacturer: Reckitt Benckiser Healthcare (UK) Limited Client order: TT18-0019

Order(s) received: 2 to 17 April 2018

Model(s): Mask: RB030VS and RB030VM Ventilator: RB030

Date(s) of tests: 26 April to 25 June 2018

Signed:

Issued: 29 June 2018

Heather Webb, Laboratory Supervisor of 18

INSPEC Test Report No: 1.18.06.57 of 18

Conditions This report may be reproduced and distributed to your clients, provided that it is reproduced and distributed in full. Unless stated otherwise, the testing is accredited under the laboratory’s ISO/IEC 17025 accreditation issued by ANSI-ASQ National Accreditation Board. Refer to certificate and scope of accreditation AT-1933. Tests marked � are not included in our ISO/IEC 17025 accreditation. Opinions, comments and interpretations expressed in this report are shown in italics. Copies of INSPEC interpretations referenced in this report are available upon request. Specimens will be disposed of four weeks from the date of this report, unless otherwise instructed. This report has been provided in accordance with our standard Terms of Business, which can be viewed at, and printed from: http://inspec-international.com/ToB.pdf If you have difficulty accessing the Terms of Business, you may contact us for a copy.


Summary of assessment*

Clause Assessment (see Key)

Model: RB030VS + RB030C RB030VM + RB030C

7.4 Packaging Ltd

7.5 Material Ltd

7.6 Cleaning and disinfecting

7.7 Practical performance Ltd

7.8 Finish of parts Pass

7.9.1 Total inward leakage Pass

7.9.2 Penetration of filter material: Sodium chloride Pass

7.9.2 Penetration of filter material: Paraffin oil Pass

7.10 Compatibility with skin

7.11 Flammability Pass

7.12 Carbon dioxide content of the inhalation air Pass

7.13 Head harness Ltd

7.14 Field of vision Ltd

7.15 Exhalation valve(s) Pass

7.16 Breathing resistance Pass

7.17 Clogging

7.18 Demountable parts Pass

9 Marking

10 Information to be supplied by the manufacturer

*RB030C - valve cap


Clause Assessment (see Key)

Model: RB030VS + RB030 RB030VM + RB030

7.4 Packaging Ltd

7.5 Material Ltd

7.6 Cleaning and disinfecting

7.7 Practical performance Pass

7.8 Finish of parts Pass

7.9.1 Total inward leakage Pass

7.9.2 Penetration of filter material: Sodium chloride

7.9.2 Penetration of filter material: Paraffin oil

7.10 Compatibility with skin Ltd

7.11 Flammability Ltd

7.12 Carbon dioxide content of the inhalation air Pass

7.13 Head harness Pass

7.14 Field of vision Pass

7.15 Exhalation valve(s) Pass

7.16 Breathing resistance Pass

7.17 Clogging

7.18 Demountable parts Pass

9 Marking

10 Information to be supplied by the manufacturer

Key

Shading shows the clauses requested. Any other clauses were not requested.

Pass Requirement satisfied.

Ltd Testing requested was insufficient completely to verify compliance with the clause. Refer to the “Result details” section for more information.

Fail Requirement not satisfied. Refer to the “Result details” section for more information.

NAs Assessment not carried out.

NAp Requirement not applicable.

NT Requested but not tested due to early termination following failure.

* Assessment relates only to those specimens which were tested and are the subject of this report.


Product characteristics

Property Characteristic

Model RB030VS mask

with RB030C valve cap

RB030VM mask

with RB030C valve cap

Classification claimed FFP1 NR FFP1 NR

Exhalation valve(s) One One

Property Characteristic

Model RB030VS mask

with RB030 ventilator

RB030VM mask

with RB030 ventilator

Classification claimed FFP1 NR FFP1 NR

Exhalation valve(s) One + ventilator One + ventilator

Submission details

Product Quantity Date

received INSPEC specimen no.

(1F0170 +)

RB030VS Dettol Protect+ filtering half mask, size Small

120

19 March 2018

101 to 163 and 301 to 363

RB030VM Dettol Protect+ filtering half mask, size Medium

120 201 to 260 and 401 to 460

RB030 Dettol Protect+ ventilator 48 501 to 520

RB030 Dettol Siti shield ventilator 48 521 to 540

RB030 Siti Shield ventilator 38 544 to 563


Procedures

The specimens detailed within the submissions above were used for the tests covered by this report.

Testing was performed in accordance with BS EN 149 : 2001 incorporating corrigendum No. 1 (July 2002) and amendment A1 (March 2009), unless otherwise specified below. Reference should be made to the standard when reading this report.

Unless stated otherwise, specimens were tested in the condition as received by INSPEC.

7.7 The client instructed that practical performance testing be carried out on one specimen of model RB030VS or RB030VM fitted with valve cap RB030C and a total of four specimens of model RB030VS or RB030VM fitted with ventilator RB030; two with the ventilator switched on and two with the ventilator switched off.

Practical performance tests were conducted in simulation of the practical use of the apparatus under the conditions prevailing in the gallery area of the laboratory. The exercises undertaken and the equipment used were as specified in the standard.

7.9.1 The client instructed that total inward leakage testing be carried out on 10 specimens of model RB030VS or RB030VM fitted with valve cap RB030C and 10 specimens of model RB030VS or RB030VM fitted with the ventilator; five with the ventilator switched on and five with the ventilator switched off.

7.9.2 Filter penetration testing by the paraffin oil method was carried out using a modified Phoenix SG-20 aerosol generator and a Phoenix model JM-6000 photometer or a TEC Services’ model PH-3 photometer. These give similar performance to the instruments specified.

For the 120 mg exposure test, the peak penetration during exposure is reported and in addition the penetration after three minutes for comparison purposes.

During the 120 mg exposure test, the sodium chloride penetration showed continued decline and the test was terminated as the product was marked NR.

The client instructed that filter penetration testing be carried out only on model RB030VS fitted with valve cap RB030C.

7.16 Exhalation resistance was tested at a continuous flow of 160 l/min.

The client instructed that breathing resistance be carried out only on model RB030VS fitted with valve cap RB030C and on model RB030VS fitted with ventilator RB030; inhalation with the ventilator switched on and exhalation with the ventilator switched off.


Result details

7.4 Packaging

Model: RB030VS + RB030C

The masks were not packaged as offered for sale. Manufacturer to certify regarding the final packaging to be used. NAs

The masks were packaged in sealed plastic bags, in larger plastic bags inside a large cardboard box that gave some protection against mechanical damage or contamination before use. Pass

Model: RB030VM + RB030

The masks were not packaged as offered for sale. Manufacturer to certify regarding the final packaging to be used. NAs

The masks were packaged in sealed plastic bags, in larger plastic bags inside a large cardboard box that gave some protection against mechanical damage or contamination before use. Pass

7.5 Material


The materials used were able to withstand handling and wear during the limited laboratory testing carried out. Ltd

The effect on materials from “in-use” environmental factors could not be evaluated during laboratory tests. Manufacturer to certify regarding such factors. NAs

Specimens 120 to 125 were conditioned in accordance with 8.3.1. None of the specimens conditioned suffered mechanical failure or collapse. Pass

Specimens 106 to 110, 117 to 119, 126 to 131, 139, 140, 156 to 158 and 161 to 163 were conditioned in accordance with 8.3.2. None of the specimens conditioned suffered collapse. Pass

The effects of filter media release were not assessed. Manufacturer to certify. NAs


The materials used were able to withstand handling and wear during the limited laboratory testing carried out. Ltd

The effect on materials from “in-use” environmental factors could not be evaluated during laboratory tests. Manufacturer to certify regarding such factors. NAs

Specimens 420 to 422 with 520 to 522 were conditioned in accordance with 8.3.1. None of the specimens conditioned suffered mechanical failure or collapse. Pass

Specimens 406 to 410, 439, 440, 446, 447, 456 to 458 with 506 to 510, 539, 540, 546, 547 and 556 to 558 respectively were conditioned in accordance with 8.3.2. None of the specimens conditioned suffered collapse. Pass

The effects of filter media release were not assessed. Manufacturer to certify. NAs


7.7 Practical performance

Model: RB030VS or RB030VM + RB030C

Specimen and subject details:

Specimen Subject

248 AH Pass

249 - NAs

No adverse comments were made following testing.

Model: RB030VS or RB030VM + RB030

Specimen and subject details:

Specimen (with ventilator on) Subject

448 + 548 ED Pass

449 + 549 VE Pass

Specimen (with ventilator off) Subject

450 + 550 RW Pass

451 + 551 ED Pass

No adverse comments were made following testing.

7.8 Finish of parts

Model: RB030VM + RB030C

None of the specimens used in laboratory testing showed evidence of sharp edges or burrs. Pass


None of the specimens used in laboratory testing showed evidence of sharp edges or burrs. Pass


7.9.1 Total inward leakage (%)


Subject Specimen Cond. Walk

Head side/ side

Head up/down

Talk Walk Mean

KDS 201 A.R. 4.12 3.53 3.33 2.95 3.94 3.58

VE 202 A.R. 1.05 0.94 1.18 1.36 0.96 1.10

KRB 203 A.R. 5.12 8.05 8.22 8.60 7.10 7.42

PBU 251 A.R. 2.12 1.67 1.58 1.81 1.62 1.76

GW 252 A.R. 0.56 0.71 0.59 2.58 0.66 1.02

ED 206 T.C. 1.29 2.02 2.41 1.94 1.94 1.92

CKN 207 T.C. 1.00 1.13 1.20 2.06 1.05 1.29

AH 208 T.C. 1.52 2.06 1.95 2.55 1.83 1.98

JLS 209 T.C. 2.76 4.46 2.94 1.96 2.60 2.94

SAH 210 T.C. 4.63 3.73 4.27 1.25 2.40 3.25

Maximum permitted 25 22

All 50 individual exercise results were not greater than 25%. Pass

All 10 individual wearer arithmetic means were not greater than 22%. Pass

Subjects EM and INH were excluded from the test panel as they were unable to achieve a satisfactory fit.

Subjects KRB, PBU, GW, CKN, AH, JLS, SAH, EM and INH commented that the mask was very small.

All test subjects chose the RB030VM (size medium) mask.



Subj.

Specimen

Cond. Walk Head side/ side

Head up/

down Talk Walk Mean

Mask

Venti-

lator

GW 401 501 on A.R. 0.45 0.76 0.52 9.86 0.81 2.48

VE 402 502 off A.R. 2.21 1.75 1.85 1.81 2.01 1.93

KRB 403 503 on A.R. 3.87 4.20 4.76 6.50 6.02 5.07

PBU 404 504 off A.R. 0.70 0.45 0.48 0.43 0.41 0.49

KDS 405 505 on A.R. 4.58 5.06 4.60 4.19 4.42 4.57

ED 406 506 off T.C. 3.36 3.59 3.54 2.87 2.99 3.27

CKN 407 507 on T.C. 0.63 0.61 0.66 0.92 0.57 0.68

AH 408 508 off T.C. 10.18 10.82 8.57 4.93 6.67 8.24

SAH 409 509 on T.C. 3.41 4.07 6.89 3.39 3.22 4.20

JLS 410 510 off T.C. 1.19 2.63 1.48 3.55 1.86 2.14

Maximum permitted 25 22

All 50 individual exercise results were not greater than 25%. Pass

All 10 individual wearer arithmetic means were not greater than 22%. Pass

All test subjects chose the RB030VM (size medium) mask.

Subject facial dimensions:

Subject

Face Length (mm)

Face Width (mm)

Face Depth (mm)

Mouth Width (mm)

KDS 102 128 98 49

VE 116 132 115 45

KRB 108 130 108 49

PBU 116 141 90 52

GW 117 133 120 53

ED 114 138 100 47

CKN 112 145 114 54

AH 119 113 115 50

JLS 122 151 120 51

SAH 112 141 123 46

EM 122 142 127 51

INH 125 153 95 58


7.9.2 Penetration of filter material


Sodium chloride: Pass

Specimen Condition

Penetration (%)

After 3 minutes

Max. during exposure

111

A.R.

3.41

112 1.34

113 2.06

120

S.W.

1.53

121 3.29

122 2.77

126

M.S. + T.C.

3.43 3.43

127 3.89 3.89

128 2.59 2.59

Maximum permitted 20

Paraffin oil: Pass

Specimen Condition

Penetration (%)

After 3 minutes

Max. during exposure

114

A.R.

14.66

115 15.79

116 6.77

123

S.W.

10.15

124 11.05

125 7.89

129

M.S. + T.C.

7.89 14.81

130 8.35 13.67

131 12.41 19.37

Maximum permitted 20

7.10 Compatibility with skin


No problems were encountered during practical performance testing. Pass

No problems were encountered during total inward leakage testing. Pass

The likelihood of materials in contact with the skin causing irritation or other adverse effect on health was not assessed. Manufacturer to certify. NAs


7.11 Flammability


Specimens 244 and 245 (A.R.) and 246 and 247 (T.C.) were tested. None of the specimens ignited. Pass

Model: RB030

Specimens 544 and 545 (A.R.) plus 546 and 547 (T.C.) were tested. None of the specimens ignited. Ltd

7.12 Carbon dioxide content of the inhalation air

Model: RB030VM + RB030C Pass

Specimen CO2 (%)

235 0.65

236 0.54

237 0.48

Maximum permitted 1.0

Model: RB030VM + RB030 Pass

Specimen (with ventilator off) CO2 (%)

435 + 535 0.51

436 + 536 0.59

437 + 537 0.52

Maximum permitted 1.0

7.13 Head harness


The head harness was designed to allow the particle filtering half-mask to be donned and removed easily during limited practical performance and total inward leakage testing. Ltd

The head harness was adjustable and there were no adverse comments regarding security following limited practical performance and total inward leakage testing. Ltd

The product satisfied the total inward leakage requirements. See 7.9.1 for results. Pass


The head harness was designed to allow the particle filtering half-mask to be donned and removed easily during practical performance and total inward leakage testing. Pass

The head harness was adjustable and there were no adverse comments regarding security following practical performance and total inward leakage testing. Pass

The product satisfied the total inward leakage requirements. See 7.9.1 for results. Pass


7.14 Field of vision


There were no adverse comments following limited practical performance tests. Ltd

Model: Model: RB030VS or RB030VM + RB030

There were no adverse comments following practical performance tests. Pass

7.15 Exhalation valve


There were no observed problems during testing of function in all orientations. See 7.16 for results. Pass

The valve was protected against dirt and mechanical damage by a cap. Pass

The product satisfied leakage requirements. See 7.9 for results. Pass

There were no observed problems when assessing operation after high exhalation flow. See 7.16 for results. Pass

The valve housing withstood 10 N applied for 10 s. Specimens 232 (A.R.), 233 (T.C.) and 234 (M.S.) were tested. Pass


There were no observed problems during testing of function in all orientations. See 7.16 for results. Pass

The valve was protected against dirt and mechanical damage by a ventilator. Pass

The product satisfied leakage requirements. See 7.9 for results. Pass

There were no observed problems when assessing operation after high exhalation flow. See 7.16 for results. Pass

The valve housing withstood 10 N applied for 10 s. Specimens 432 (A.R.), 456 (T.C.) and 434 (M.S.) were tested. Pass


7.16 Breathing resistance

Model: RB030VS + RB030C Pass

Specimen Condition Inhalation resistance (mbar)

Exhalation resistance (mbar)

At 30 l/min At 95 l/min At 160 l/min

111

A.R.

0.46 1.62 1.96

112 0.57 2.03 2.24

113 0.57 1.80 2.19

117

T.C.

0.53 1.85 2.02

118 0.50 1.68 2.03

119 0.59 2.07 2.20

120

S.W.

0.57 1.88 2.14

121 0.57 1.95 2.20

122 0.50 1.63 1.87

138 A.R. + F.C. 0.56 1.89 2.27

139 T.C. + F.C.

0.51 1.77 2.20

140 0.53 1.78 2.23

Maximum permitted 0.6 2.1 3.0


Specimen Condition Inhalation resistance (mbar)



211

A.R.

Not requested

NAs

212 NAs

213 NAs

217

T.C.

NAs

218 NAs

219 NAs

220

S.W.

NAs

221 NAs

222 NAs

238 A.R. + F.C. 0.40 1.30 1.65 Pass

239 T.C. + F.C.

0.36 1.20 1.61 Pass

240 0.36 1.26 1.65 Pass



Model: RB030VS + RB030 Pass

Specimen

Condition

Inhalation resistance (mbar) – ventilator on

Exhalation resistance (mbar) –

ventilator off

Mask

Venti-lator


311 511

A.R.

0.59 1.94 2.11

312 512 0.51 1.77 2.06

313 513 0.57 1.87 2.12

317 517

T.C.

0.56 1.82 2.11

318 518 0.59 1.97 2.20

319 519 0.57 1.85 2.07

320 520

S.W.

0.59 1.88 2.24

321 521 0.54 1.75 2.22

322 522 0.57 1.71 2.26

338 538 A.R. + F.C. 0.53 1.84 2.10

339 539 T.C. + F.C.

0.51 1.65 1.97

340 540 0.51 1.69 2.10



Specimen

Condition

Inhalation resistance (mbar)


Mask

Venti-lator


411 511

A.R.

Not requested

412 512

413 513

417 517

T.C.

418 518

419 519

420 520

S.W.

421 521

422 522

438 538 A.R. + F.C. 0.41 1.25 1.58

439 539 T.C. + F.C.

0.43 1.39 1.82

440 540 0.41 1.24 1.63



7.18 Demountable parts


The following parts were demountable: the exhalation valve cover was readily connected by hand. Pass


The following parts were demountable: the micro ventilator was readily connected by hand. Pass


Estimates of the uncertainty of measurement

Clause Test Uncertainty

7.4 Packaging Not applicable

7.5 Material See Note 1

7.6 Cleaning and disinfecting Not applicable

7.7 Practical performance See Note 1

7.8 Finish of parts Not applicable

7.9.1 Total inward leakage ± 4.8%

7.9.2 Penetration of filter material - Sodium chloride ± 4.8%

7.9.2 Penetration of filter material - Paraffin oil ± 4.3%

7.10 Compatibility with skin Not applicable

7.11 Flammability See Note 1

7.12 CO2 content of the inhalation air ± 8.0%

7.13 Head harness Not applicable

7.14 Field of vision See Note 1

7.15 Exhalation valve(s) See Note 1

7.16 Breathing resistance ± 4.9%

7.17.2 Breathing resistance after clogging ± 7.7%

7.17.3 Filter penetration after clogging - Sodium chloride ± 4.8%

7.17.3 Filter penetration after clogging - Paraffin oil ± 4.3%

7.18 Demountable parts Not applicable

Note 1 The acceptance criterion for this test is a straightforward “Pass/Fail”, rather than a

numerical value. Consequently, as there is no value to be reported, uncertainty has not been reported either.

Note 2 The uncertainty value is based on a standard uncertainty multiplied by a coverage factor

k = 2, which provides for a confidence level of approximately 95%. Values expressed as a percentage (%) are relative.

Note 3 It should be noted that the above values have not been taken into account when making

assessment to the pass/fail criteria.


ANNEX

This Annex comprises one section.

1. Photographs of the products tested. (5 pages)

END OF REPORT

Reckitt Benckiser Healthcare (UK) Limited Filtering half mask, model: RB030VS (size S) fitted with valve cap RB030C

INSPEC Testing Services’ specimen number 1F0170 160 29 June 2018

Reckitt Benckiser Healthcare (UK) Limited Filtering half mask, model RB030VM (size M) fitted with valve cap RB030C

INSPEC Testing Services’ specimen number 1F0170 260 29 June 2018

Reckitt Benckiser Healthcare (UK) Limited Filtering half mask, model RB030VS (size S) fitted with ventilator RB030

INSPEC Testing Services’ specimen number 1F0170 360 and 560 28 June 2018

Reckitt Benckiser Healthcare (UK) Limited filtering half mask, model: RB030VM (size M) fitted with ventilator RB030

INSPEC Testing Services’ specimen number 1F0170 460 and 560 28 June 2018

Reckitt Benckiser Healthcare (UK) Limited Ventilator: RB030 Siti Shield

INSPEC Testing Services’ specimen number 1F0170 560 27 April 2018

1.18.06.57 1f0170 draft report · 2020-05-05 · nas the masks were packaged in sealed plastic...

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